FDA Product Code
FDA Product Code GJS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7750
510(k) Clearances — 127 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | 2025-10-24 | Special | PDF ↗ |
| K251564 | microINR System | Iline Microsystems, S.L. | 2025-07-21 | Traditional | PDF ↗ |
| K243543 | microINR System | Iline Microsystems, S.L. | 2025-02-27 | Traditional | PDF ↗ |
| K230802 | Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. | 2024-03-15 | Dual Track | PDF ↗ |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Abbott Laboratories | 2023-07-14 | Traditional | PDF ↗ |
| K231711 | microINR System | Iline Microsystems, S.L. | 2023-07-11 | Special | PDF ↗ |
| K211485 | STA- NeoPTimal | Diagnostica Stago S.A.S | 2022-12-23 | Traditional | PDF ↗ |
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | Coagusense, Inc. | 2022-10-05 | Special | PDF ↗ |
| K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory CO | 2022-08-16 | Traditional | PDF ↗ |
| K201185 | microINR System | Iline Microsystems, S.L. | 2020-12-18 | Traditional | PDF ↗ |
| K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | 2019-02-21 | Traditional | PDF ↗ |
| K180780 | microINR System | Iline Microsystems, S.L. | 2019-01-25 | Traditional | PDF ↗ |
| K180693 | CoaguChek XS Pro System | Roche Diagnostics | 2018-04-19 | Special | PDF ↗ |
| K180684 | CoaguChek XS Plus System | Roche Diagnostics | 2018-04-19 | Special | PDF ↗ |
| K170960 | CoaguChek Vantus System | Roche Diagnostics | 2017-12-25 | Traditional | PDF ↗ |
| K151964 | Xprecia Stride Coagulation System, Xprecia System PT Controls | Siemens Healthcare Diagnostics | 2016-09-30 | Traditional | PDF ↗ |
| K132722 | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) | Instrumentation Laboratory CO | 2014-01-22 | Special | PDF ↗ |
| K122584 | HEMOSIL READIPLAS TIN | Instrumentation Laboratory CO | 2013-03-24 | Traditional | PDF ↗ |
| K110212 | INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP | Alere San Diego, Inc (Formally Biosite Incorporate | 2012-05-01 | Traditional | PDF ↗ |
| K092987 | INRATIO/INRATIO2 TEST STRIPS | Biosite Incorporated | 2010-06-11 | Traditional | PDF ↗ |
| K093243 | COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM | Coagusense, Inc. | 2010-04-07 | Traditional | PDF ↗ |
| K093460 | COAGUCHEK XS PRO SYSTEM | Roche Diagnostics | 2010-03-18 | Traditional | PDF ↗ |
| K092940 | COAGUCHEK XS PLUS PST SYSTEM | Roche Diagnostics Corp. | 2010-03-05 | Traditional | PDF ↗ |
| K072920 | HANDHELD BASE UNIT | Roche Diagnostics Corp. | 2008-01-31 | Abbreviated | PDF ↗ |
| K072727 | INRATIO 2 PT MONITORING SYSTEM | Hemosense, Inc. | 2007-10-26 | Special | PDF ↗ |
| K070005 | HEMOSIL RECOMBIPLASTIN 2G | Instrumentation Laboratory CO | 2007-08-15 | Traditional | PDF ↗ |
| K071041 | COAGUCHEK XS PLUS SYSTEM | Roche Diagnostics | 2007-05-11 | Special | PDF ↗ |
| K062925 | COAGUCHEK XS SYSTEM | Roche Diagnostics Corp. | 2007-01-29 | Traditional | PDF ↗ |
| K060978 | COAGUCHEK XS SYSTEM | Roche Diagnostics | 2006-08-11 | Traditional | PDF ↗ |
| K060931 | HEMOSIL PT-FIBRINOGEN HS PLUS | Instrumentation Laboratory CO | 2006-05-02 | Special | PDF ↗ |
| K052124 | ACTICLOT, MODEL 824 | American Diagnostica, Inc. | 2005-10-17 | Traditional | PDF ↗ |
| K043184 | HEMOSIL RECOMBIPLASTIN | Instrumentation Laboratory CO | 2004-12-22 | Special | PDF ↗ |
| K040296 | PHOSPHOPLASTIN RL | R2 Diagnostics, Inc. | 2004-05-24 | Traditional | PDF ↗ |
| K030845 | COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING | Roche Diagnostics Corp. | 2003-05-22 | Traditional | PDF ↗ |
| K021190 | PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 | Roche Diagnostics Corp. | 2002-10-25 | Traditional | PDF ↗ |
| K021923 | INRATIO SELF-TEST | Hemosense, Inc. | 2002-10-24 | Traditional | PDF ↗ |
| K020831 | PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 | Roche Diagnostics Corp. | 2002-10-24 | Traditional | PDF ↗ |
| K022922 | HARMONY INR MONITORING SYSTEM | Lifescan, Inc. | 2002-09-30 | Special | PDF ↗ |
| K020840 | VITAL SCIENTIFIC PT WITH CALCIUM | Vital Scientific N.V. | 2002-05-15 | Traditional | PDF ↗ |
| K020355 | I-STAT PROTHROMBIN TIME TEST | I-Stat Corporation | 2002-05-14 | Traditional | PDF ↗ |
| K020679 | INRATIO | Hemosense, Inc. | 2002-05-06 | Traditional | PDF ↗ |
| K013155 | DADE THROMBOPLASTIN C PLUS | Dade Behring, Inc. | 2002-01-18 | Traditional | PDF ↗ |
| K012768 | HEMOSIL RECOMBI PLASTIN | Instrumentation Laboratory CO | 2001-09-18 | Traditional | PDF ↗ |
| K010599 | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE | International Technidyne Corp. | 2001-07-02 | Special | PDF ↗ |
| K001699 | RUBICON PROTHROMBIN TIME MONITORING SYSTEM | Lifescan, Inc. | 2001-05-15 | Traditional | PDF ↗ |
| K003870 | THROMBOREL S | Dade Behring, Inc. | 2001-02-20 | Traditional | PDF ↗ |
| K994100 | PACIFIC HEMOSTASIS THROMBOPLASTIN D | Pacific Hemostasis | 2000-02-18 | Traditional | PDF ↗ |
| K994006 | AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) | Avocet Medical, Inc. | 2000-02-03 | Traditional | PDF ↗ |
| K991286 | AVOCET ACUSURE SYSTEM | Avocet Medical, Inc. | 1999-11-18 | Traditional | PDF ↗ |
| K992492 | PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM | Roche Diagnostics Corp. | 1999-11-02 | Traditional | PDF ↗ |
| K991065 | CARESIDE PT | Careside, Inc. | 1999-07-26 | Traditional | PDF ↗ |
| K972866 | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT | International Technidyne Corp. | 1998-09-30 | Traditional | PDF ↗ |
| K974343 | DADE INNOVIN | Dade Intl., Inc. | 1998-07-22 | Traditional | PDF ↗ |
| K981479 | IL TEST PT-FIBRINOGEN RECOMBINANT | Instrumentation Laboratory CO | 1998-07-07 | Traditional | PDF ↗ |
| K974566 | MDA SIMPLASTIN HTF | Organon Teknika Corp. | 1998-02-24 | Traditional | PDF ↗ |
| K972796 | SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM | Sigma Diagnostics, Inc. | 1997-10-10 | Traditional | PDF ↗ |
| K962571 | COAGUCHEK PST SYSTEM | Boehringer Mannheim Corp. | 1997-04-22 | Traditional | PDF ↗ |
| K961835 | PROTIME MICROCOAGULATION SYSTEM | International Technidyne Corp. | 1997-03-12 | Traditional | PDF ↗ |
| K961938 | STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS | Nova Biomedical Corp. | 1996-06-28 | Traditional | PDF ↗ |
| K955843 | TAS PTONE | Cardiovascular Diagnostic Services | 1996-03-18 | Traditional | PDF ↗ |
| K954625 | PROTHROMBIN TIME TEST CARD | Cardiovascular Diagnostics, Inc. | 1996-03-11 | Traditional | PDF ↗ |
| K951820 | THROMBOPLASTIN-LI REAGENT | Helena Laboratories | 1995-10-20 | Traditional | PDF ↗ |
| K952608 | MDA SIMPLASTIN LS | Organon Teknika Corp. | 1995-10-06 | Traditional | PDF ↗ |
| K942884 | COAGUCHEK SYSTEM | Boehringer Mannheim Corp. | 1995-05-11 | Traditional | PDF ↗ |
| K945078 | HEMOCHRON HNPT/FACTOR VI PT+ | International Technidyne Corp. | 1995-04-28 | Traditional | PDF ↗ |
| K935748 | ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT | Ortho Diagnostic Systems, Inc. | 1995-04-26 | Traditional | PDF ↗ |
| K940082 | THROMBOSCREEN THROMBOPLASTIN-DS | Pacific Hemostasis | 1995-02-14 | Traditional | PDF ↗ |
| K935702 | DADE INNOVIN II | Baxter Diagnostics, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K940432 | MICROCOAGULATION PROTHROMBIN TIME TEST | International Technidyne Corp. | 1994-05-18 | Traditional | PDF ↗ |
| K940310 | HELENA THROMBOPLASTIN-MI REAGENT | Helena Laboratories | 1994-04-20 | Traditional | PDF ↗ |
| K931117 | ASSESS(TM) LOW ABNORMAL CONTROL | Instrumentation Laboratory CO | 1994-03-30 | Traditional | PDF ↗ |
| K931118 | ASSESS(TM) HIGH ABNORMAL CONTROL | Instrumentation Laboratory CO | 1994-03-30 | Traditional | PDF ↗ |
| K933252 | IL TEST (TM) PT-FIBRINOGEN HS PLUS | Instrumentation Laboratory CO | 1993-10-04 | Traditional | PDF ↗ |
| K930212 | THROMBOPLATIN-M WITH CALCIUM | Sigma Diagnostics, Inc. | 1993-05-11 | Traditional | PDF ↗ |
| K925604 | ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT | Ortho Diagnostic Systems, Inc. | 1993-03-12 | Traditional | PDF ↗ |
| K920767 | NYCOPLASTIN | Nycomed Pharma AS | 1993-02-12 | Traditional | PDF ↗ |
| K925492 | BIOMERIEUX HEMOLAB THROMBOMAT | Biomerieux Vitek, Inc. | 1993-02-03 | Traditional | PDF ↗ |
| K922565 | NEOPLASTINE(R) CI KIT | American Bioproducts Co. | 1992-12-07 | Traditional | PDF ↗ |
| K921326 | DADE RECOMBOPLASTIN S | Baxter Diagnostics, Inc. | 1992-07-27 | Traditional | PDF ↗ |
| K922040 | NEOPLASTINE CI PLUS | American Bioproducts Co. | 1992-06-23 | Traditional | PDF ↗ |
| K915746 | SIMPLASTIN L | Organon Teknika Corp. | 1992-02-12 | Traditional | PDF ↗ |
| K913249 | ACS ULTRA-1 THROMBOPLASTIN | Analytical Control Systems, Inc. | 1991-12-04 | Traditional | PDF ↗ |
| K913250 | ACS ULTRA-2 THROMBOPLASTIN | Analytical Control Systems, Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K912102 | ACS LIQUID THROMBOPLASTIN | Analytical Control Systems, Inc. | 1991-08-09 | Traditional | PDF ↗ |
| K911995 | PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION | International Technidyne Corp. | 1991-07-17 | Traditional | PDF ↗ |
| K905807 | HELENA THROMBOPLASTIN REAGENT WITH DILUENT | Helena Laboratories | 1991-04-16 | Traditional | PDF ↗ |
| K905857 | HELENA THROMBOPLASTIN REAGENT, MODIFICATION | Helena Laboratories | 1991-02-27 | Traditional | PDF ↗ |
| K904325 | COAG-1 PT-NC TEST CARD | Cardiovascular Diagnostic Services | 1991-01-25 | Traditional | PDF ↗ |
| K904454 | HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION | International Technidyne Corp. | 1990-12-17 | Traditional | PDF ↗ |
| K902468 | ACS ONE-STAGE PROTHROMBIN TIME REAGENT | Analytical Control Systems, Inc. | 1990-08-10 | Traditional | PDF ↗ |
| K903019 | MODIFIED COAG-1 PT TEST CARD | Cardiovascular Diagnostic Services | 1990-08-01 | Traditional | PDF ↗ |
| K902096 | THROMBOPLASTIN WITH CALCIUM | Sigma Chemical Co. | 1990-07-03 | Traditional | PDF ↗ |
| K901325 | THROMBOPLASTIN.C PLUS | Baxter Healthcare Corp | 1990-05-02 | Traditional | PDF ↗ |
| K896625 | THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. | Medical Diagnostic Technologies, Inc. | 1989-12-11 | Traditional | PDF ↗ |
| K885107 | THROMBOSTIN IFA* | Investigacion Farmaceutica S.A. DE C.V. | 1989-06-23 | Traditional | PDF ↗ |
| K893378 | PROTHROMBIN TIME (PT) BY HEMOCHRON | International Technidyne Corp. | 1989-06-22 | Traditional | PDF ↗ |
| K892050 | HELENA THROMBOPLASTIN REAGENT | Helena Laboratories | 1989-06-07 | Traditional | PDF ↗ |
| K891370 | EDL ONE-STAGE PROTHROMBIN TIME REAGENT | Elite Diagnostic , Ltd. | 1989-04-21 | Traditional | PDF ↗ |
| K891169 | DADE THROMBOPLASTIN IS | Baxter Healthcare Corp | 1989-04-10 | Traditional | PDF ↗ |
| K884855 | THROMBOPLASTIN | Precision Biologicals, Inc. | 1989-01-30 | Traditional | PDF ↗ |
Product code GJS · Class II · Hematology. Data: openFDA.