NQD — Cardiac C-Reactive Protein, Antigen, Antiserum, And Control Class II
Classification Details
- Product Code
- NQD
- Device Class
- Class II
- Regulation Number
- 866.5270
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233242 | siemens healthcare diagnostics | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | January 18, 2024 |
| K212559 | siemens healthcare diagnostics products | CardioPhase® hsCRP | December 16, 2022 |
| K173833 | sentinel ch | CRP Vario | September 27, 2018 |
| K081294 | siemens healthcare diagnostics | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRA | July 29, 2008 |
| K071002 | beckman coulter | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP | June 21, 2007 |
| K070626 | beckman coulter | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT | May 4, 2007 |
| K071017 | siemens medical solutions diagnostics | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5 | May 2, 2007 |
| K062924 | dade behring | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK | December 26, 2006 |
| K063057 | diagnostic products corporation | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | December 22, 2006 |
| K061802 | dade behring | DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, | September 11, 2006 |
| K060369 | dade behring | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK | May 4, 2006 |
| K053603 | roche diagnostics | C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUME | February 9, 2006 |
| K053109 | dade behring | DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE | December 23, 2005 |
| K051564 | olympus america | OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC | August 22, 2005 |
| K042485 | roche diagnostics | TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE | October 29, 2004 |
| K041799 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KI | August 25, 2004 |
| K041668 | olympus america | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT | August 19, 2004 |
| K033908 | dade behring | N HIGH SENSITIVITY CRP | January 22, 2004 |