FDA 510(k) Applications for Medical Device Product Code "NQD"
(Cardiac C-Reactive Protein, Antigen, Antiserum, And Control)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K071002 | BECKMAN COULTER, INC. | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT | 06/21/2007 |
| K070626 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT | 05/04/2007 |
| K053109 | DADE BEHRING, INC. | DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE | 12/23/2005 |
| K061802 | DADE BEHRING, INC. | DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH | 09/11/2006 |
| K033908 | DADE BEHRING, INC. | N HIGH SENSITIVITY CRP | 01/22/2004 |
| K060369 | DADE BEHRING, INC. | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK | 05/04/2006 |
| K062924 | DADE BEHRING, INC. | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK | 12/26/2006 |
| K063057 | DIAGNOSTIC PRODUCTS CORPORATION | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | 12/22/2006 |
| K041668 | OLYMPUS AMERICA INC. | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT | 08/19/2004 |
| K051564 | OLYMPUS AMERICA, INC. | OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH | 08/22/2005 |
| K041799 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS | 08/25/2004 |
| K053603 | ROCHE DIAGNOSTICS CORP. | C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS | 02/09/2006 |
| K042485 | ROCHE DIAGNOSTICS CORP. | TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) | 10/29/2004 |
| K173833 | SENTINEL CH. SpA | CRP Vario | 09/27/2018 |
| K081294 | Siemens Healthcare Diagnostics Inc. | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS | 07/29/2008 |
| K212559 | Siemens Healthcare Diagnostics Products GmbH | CardioPhase« hsCRP | 12/16/2022 |
| K071017 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) | 05/02/2007 |
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