FDA Product Code
FDA Product Code NQD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5270
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | 2026-04-02 | Traditional | PDF ↗ |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. | 2024-01-18 | Traditional | PDF ↗ |
| K212559 | CardioPhase® hsCRP | Siemens Healthcare Diagnostics Products GmbH | 2022-12-16 | Special | PDF ↗ |
| K173833 | CRP Vario | SENTINEL CH. SpA | 2018-09-27 | Traditional | PDF ↗ |
| K081294 | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | 2008-07-29 | Traditional | PDF ↗ |
| K071002 | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT | Beckman Coulter, Inc. | 2007-06-21 | Traditional | PDF ↗ |
| K070626 | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT | Beckman Coulter, Inc. | 2007-05-04 | Traditional | PDF ↗ |
| K071017 | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) | Siemens Medical Solutions Diagnostics | 2007-05-02 | Special | PDF ↗ |
| K062924 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK | Dade Behring, Inc. | 2006-12-26 | Traditional | PDF ↗ |
| K063057 | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | Diagnostic Products Corporation | 2006-12-22 | Abbreviated | PDF ↗ |
| K061802 | DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH | Dade Behring, Inc. | 2006-09-11 | Traditional | PDF ↗ |
| K060369 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK | Dade Behring, Inc. | 2006-05-04 | Traditional | PDF ↗ |
| K053603 | C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS | Roche Diagnostics Corp. | 2006-02-09 | Traditional | PDF ↗ |
| K053109 | DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2005-12-23 | Traditional | PDF ↗ |
| K051564 | OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH | Olympus America, Inc. | 2005-08-22 | Traditional | PDF ↗ |
| K042485 | TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) | Roche Diagnostics Corp. | 2004-10-29 | Traditional | PDF ↗ |
| K041799 | VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS | Ortho-Clinical Diagnostics, Inc. | 2004-08-25 | Traditional | PDF ↗ |
| K041668 | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 2004-08-19 | Traditional | PDF ↗ |
| K033908 | N HIGH SENSITIVITY CRP | Dade Behring, Inc. | 2004-01-22 | Traditional | PDF ↗ |
Product code NQD · Class II · Immunology. Data: openFDA.