Review Panel
Hematology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,197
- Product Codes (page)
- 38
- Latest Decision
- 2026-09-24
Clearances · page 1 of 42
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K260214 | STA® - Liquid Anti-Xa | Diagnostica Stago, Inc. | KFF | Class II | 2026-09-24 |
| K260781 | Yumizen H550 | HORIBA ABX SAS | GKZ | Class II | 2026-09-14 |
| K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | Siemens Healthcare Diagnostic Products GmbH | DAP | Class II | 2026-08-11 |
| K260755 | OptraSCAN System | Optrascan, Inc. | NOT | Class II | 2026-07-02 |
| K261099 | Blood Volume Analyzer (200) | Daxor Corporation | JWO | Class II | 2026-06-18 |
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. | GKZ | Class II | 2026-05-27 |
| K253658 | STA Satellite Max® | Diagnostica Stago, Inc. | JPA | Class II | 2026-04-27 |
| K252228 | Seaman Pro/Seaman | Checkcells, Inc. | POV | Class II | 2026-04-09 |
| K260551 | HemosIL Factor V Leiden (APC Resistance V) | Instrumentation Laboratory (IL) Co. | GGW | Class II | 2026-03-20 |
| K243348 | Athelas Home | Athelas, Inc. | GKZ | Class II | 2026-02-06 |
| K251249 | Tru Hematology Test | Truvian Sciences, Inc. | GKZ | Class II | 2026-01-16 |
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | GFO | Class II | 2026-01-09 |
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | GJS | Class II | 2025-10-24 |
| DEN240067 | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | Cytocell Limited | SFS | Class II | 2025-09-19 |
| K252580 | iQ200 Series | Beckman Coulter, Inc. | LKM | Class II | 2025-09-10 |
| K251404 | Quantra QStat Cartridge | Hemosonics, LLC | QFR | Class II | 2025-08-25 |
| K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | GGP | Class II | 2025-08-25 |
| K251087 | Blood Volume Analyzer (200) | Daxor Corporation | JWO | Class II | 2025-08-04 |
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. | KQJ | Class II | 2025-07-24 |
| K251564 | microINR System | Iline Microsystems, S.L. | GJS | Class II | 2025-07-21 |
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | JOY | Class II | 2025-06-27 |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | 2025-06-25 |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | 2025-06-25 |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | Sysmex America, Inc. | JPA | Class II | 2025-06-02 |
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | POV | Class II | 2025-05-30 |
| DEN240035 | ConcizuTrace ELISA | Randox Laboratories, Ltd. | SES | Class II | 2025-05-22 |
| K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | POV | Class II | 2025-05-09 |
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | POV | Class II | 2025-05-02 |
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics | JPA | Class II | 2025-04-30 |
| K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH | JBQ | Class II | 2025-03-28 |
| K243543 | microINR System | Iline Microsystems, S.L. | GJS | Class II | 2025-02-27 |
| K250218 | Xpert® FII & FV | Cepheid | NPR | Class II | 2025-02-21 |
| K243283 | Alinity h-series System | Abbott Laboratories | GKZ | Class II | 2025-02-20 |
| K240402 | Cito CBC System | Cytochip, Inc. | GKZ | Class II | 2025-02-03 |
| K243374 | HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. | LCO | Class II | 2025-01-28 |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation | JPA | Class II | 2025-01-15 |
| DEN240025 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) | Ventana Medical Systems, Inc. | SDP | Class II | 2024-12-05 |
| K241628 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | POV | Class II | 2024-11-29 |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | LCP | Class II | 2024-11-22 |
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | Siemens Healthcare Diagnostics Products GmbH | QLU | Class II | 2024-10-10 |
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | Instrumentation Laboratory (IL) Co. | GKP | Class II | 2024-08-16 |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System | Beckman Coulter, Inc. | GKZ | Class II | 2024-07-05 |
| K232946 | Yumizen H2500 | HORIBA ABX SAS | GKZ | Class II | 2024-05-21 |
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray, Inc. | LKM | Class II | 2024-05-03 |
| K240636 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies | GKZ | Class II | 2024-05-02 |
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips | Urit Medical Electronic Co., Ltd. | JIO | Class II | 2024-04-26 |
| K240182 | Access EPO | Beckman Coulter, Inc. | GGT | Class II | 2024-04-22 |
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia | GKA | Class II | 2024-04-04 |
| K232018 | Citrated: K, KH, RTH, FFH | Haemonetics Corporation | JPA | Class II | 2024-03-29 |
| K240045 | QStat Cartridge | Hemosonics, LLC | QFR | Class II | 2024-03-27 |
| DEN230034 | X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application | Scopio Labs , Ltd. | SAL | Class II | 2024-03-22 |
| K230802 | Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. | GJS | Class II | 2024-03-15 |
| DEN230024 | Technozym ADAMTS13 Activity | Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM | SAC | Class II | 2024-02-28 |
| K233790 | ACL TOP 970 CL | Instrumentation Laboratory | JPA | Class II | 2023-12-29 |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | 2023-12-21 |
| K230852 | HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company | GGP | Class II | 2023-12-13 |
| K231465 | Q-Pad Test System | Qurasense | LCP | Class II | 2023-12-06 |
| K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | Beckman Coulter, Inc. | OYE | Class II | 2023-11-22 |
| K230878 | QScout Lab; QScout RLD | Ad Astra Diagnostics, Inc. | GKZ | Class II | 2023-11-14 |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | Instrumentation Laboratory CO | JPA | Class II | 2023-09-29 |
| K221508 | AnemoCheck Home | Sanguina, Inc. | KHG | Class II | 2023-09-29 |
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | Abbott Diagnostics Technologies AS | LCP | Class II | 2023-09-27 |
| K221309 | AI100 with Shonit | Sigtuple Technologies Pvt. , Ltd. | JOY | Class II | 2023-09-19 |
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | GJT | Class II | 2023-09-13 |
| K232215 | Quantra Hemostasis Analyzer | Hemosonics, LLC | QFR | Class II | 2023-08-24 |
| K222148 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | GKZ | Class II | 2023-08-16 |
| K220828 | SQA-iO Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | POV | Class II | 2023-08-07 |
| K220031 | Alinity h-series System | Abbott Laboratories | GKZ | Class II | 2023-08-04 |
| K222635 | Premier Resolution System | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | GKA | Class II | 2023-08-04 |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Abbott Laboratories | GJS | Class II | 2023-07-14 |
| K231711 | microINR System | Iline Microsystems, S.L. | GJS | Class II | 2023-07-11 |
| K223187 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | QLU | Class II | 2023-06-23 |
| K231031 | ACL TOP Family 70 Series | Instrumentation Laboratory Company | GKP | Class II | 2023-06-21 |
| K231045 | Healgen URS Test Strips | Healgen Scientific,, LLC | LJX | Class I | 2023-06-16 |
| K212183 | STA R Max 3, STA Compact Max 3 | Diagnostica Stago S.A.S | JPA | Class II | 2023-06-07 |
| K220728 | vWF Ag | Siemens Healthcare Diagnostics Products GmbH | GGP | Class II | 2023-06-02 |
| K230461 | Quantra Hemostasis Analyzer | Hemosonics, LLC | QFR | Class II | 2023-03-24 |
| K223046 | Xpert® FII & FV | Cepheid® | NPR | Class II | 2023-02-15 |
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | Sienco, Inc. | JBP | Class II | 2023-01-04 |
| K214002 | CRYOcheck Chromogenic Factor IX | Precision Biologic, Inc. | GGP | Class II | 2022-12-23 |
| K211485 | STA- NeoPTimal | Diagnostica Stago S.A.S | GJS | Class II | 2022-12-23 |
| K223433 | Quantra QPlus System | Hemosonics, LLC | QFR | Class II | 2022-12-13 |
| K223402 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | GGP | Class II | 2022-12-09 |
| K213917 | QStat Cartridge | Hemosonics, LLC | QFR | Class II | 2022-11-29 |
| K210346 | Sysmex XW-100 Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | 2022-11-08 |
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | Coagusense, Inc. | GJS | Class II | 2022-10-05 |
| K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | KFF | Class II | 2022-10-04 |
| DEN200067 | INNOVANCE VWF Ac | Siemens Healthcare Diagnostics Products GmbH | QTY | Class II | 2022-09-29 |
| K201049 | FINDER G6PD | Baebies, Inc. | JBF | Class II | 2022-09-14 |
| K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory CO | GJS | Class II | 2022-08-16 |
| K220163 | Her-2, ER, PR IHControls | Boston Cell Standards, Inc. | NJW | Class II | 2022-08-15 |
| K201440 | ROTEM sigma Thromboelastometry System | Tem Innovations GmbH | JPA | Class II | 2022-07-08 |
| K200754 | Hemosure Accu-Reader A100 | W.H.P.M., Inc. | OOX | Class II | 2022-06-02 |
| K211840 | Sight OLO | S.D. Sight Diagnostics , Ltd. | GKZ | Class II | 2022-05-09 |
| K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | JOY | Class II | 2022-05-03 |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | Helena Laboratories, Corp. | GKA | Class II | 2022-04-19 |
| K200828 | Athelas Home | Athelas, Inc. | GKZ | Class II | 2022-03-22 |
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 | Accriva Diagnostics, Inc. | JPA | Class II | 2021-12-29 |
| K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. | LKM | Class II | 2021-07-02 |
| K201185 | microINR System | Iline Microsystems, S.L. | GJS | Class II | 2020-12-18 |
4,197 clearances in the Hematology panel. Data: openFDA.