Panels › Immunology › Product code DCN · Class 2
System, Test, C-Reactive Protein
Regulation 866.5270
0510(k)s in 12 months (70 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in DCN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 27, 2023 | K232624 | CardioPhase® hsCRP Siemens Healthcare Diagnostic Products GmbH, DE | DCN |
| Mar 17, 2023 | K221119 | RCRP Flex reagent cartridge Siemens Healthcare Diagnostics, Inc. | DCN |
| Feb 21, 2020 | K192072 | Tina-quant C-Reactive Protein IV Roche Diagnostics Operations (Rdo) | DCN |
| Oct 12, 2018 | K180099 | Optilite High Sensitivity C-Reactive Protein Kit The Binding Site Group , Ltd., GB | DCN |
| Feb 28, 2018 | K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls The Binding Site Group , Ltd., GB | DCN |
| Jan 12, 2018 | K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 Instrument Meso Scale Diagnostics, LLC | DCN |
| Apr 5, 2017 | K161982 | C-Reactive Protein Kit for use on SPAPLUS The Binding Site Group, GB | DCN |
| Aug 17, 2012 | K113809 | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) Hitachi Chemical Diagnostics, Inc. | DCN |
| Jan 15, 2010 | K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM Abaxis, Inc. | DCN |
| Mar 18, 2009 | K083444 | C-REACTIVE PROTEIN (LATEX) Roche Diagnostics Corp. | DCN |
| Mar 9, 2009 | K083412 | PATHFAST HSCRP Mitsubishi Kagaku Iatron | DCN |
| Jan 30, 2009 | K083040 | S-TEST C-REACTIVE PROTEIN (CRP) Alfa Wassermann Diagnostic Technologies, Inc. | DCN |
| Apr 1, 2008 | K072658 | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS Siemens Medical Solutions Diagnostics | DCN |
| Mar 6, 2008 | K073277 | ROCHE-CREACTIVE PROTEIN (LATEX) Roche Diagnostics Corp. | DCN |
| Jul 13, 2007 | K062981 | I-CHROMA CRP TEST Boditech Diagnostics, Inc. | DCN |
| Sep 6, 2006 | K061825 | DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH Dade Behring, Inc. | DCN |
| Jun 6, 2005 | K050713 | DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 Good Biotech Corp., TW | DCN |
| Jun 16, 2004 | K040030 | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 Biocheck, Inc. | DCN |
| Aug 5, 2003 | K032336 | TINA-QUANT CRP (LATEX) Roche Diagnostics Corp. | DCN |
| Jul 2, 2003 | K030899 | C-REACTIVE PROTEIN (CRP) Abbott Laboratories | DCN |
| Dec 23, 2002 | K022690 | PAROS CRP Horiba, Ltd. | DCN |
| Jul 29, 2002 | K021757 | CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET Good Biotech Corp., TW | DCN |
| Jul 19, 2002 | K021572 | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR Beckman Coulter, Inc. | DCN |
| Jul 11, 2002 | K021882 | CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 Good Biotech Corp., CN | DCN |
| Jun 13, 2002 | K020603 | CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 Good Biotech Corp., TW | DCN |
| Jan 8, 2002 | K011855 | WAMPOLE HS-CRP ELISA Carter-Wallace, Inc. | DCN |
| Dec 6, 2001 | K012337 | BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM Bayer Corp. | DCN |
| Dec 4, 2001 | K011958 | CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT Denka Seiken'S, JP | DCN |
| May 10, 2001 | K003400 | CRP HS TEST SYSTEM Roche Diagnostics Corp. | DCN |
| Feb 14, 2001 | K003419 | RCRP FLEX REAGENT CARTRIDGE Dade Behring, Inc. | DCN |
| Jan 22, 2001 | K003342 | WAKO CRP-UL, CRP-UL CALIBRATOR SET Wako Chemicals USA, Inc. | DCN |
| Dec 26, 2000 | K003372 | IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP Diagnostic Products Corp. | DCN |
| Oct 25, 2000 | K002918 | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. | DCN |
| Jun 1, 1999 | K991372 | CRP Abbott Laboratories | DCN |
| Apr 16, 1999 | K990825 | REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE Dade Behring, Inc. | DCN |
| Feb 18, 1998 | K974429 | RAPET CRP Stanbio Laboratory | DCN |
| Feb 14, 1996 | K954537 | OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. | DCN |
| Dec 13, 1995 | K955042 | CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM Shared Systems, Inc. | DCN |
| Jan 11, 1994 | K935075 | SPQ CRP CONTROL LEVEL II Incstar Corp. | DCN |
| Aug 23, 1993 | K932180 | EYE SPOT CRP TEST J.S. Medical Assoc. | DCN |
| Apr 12, 1991 | K910535 | SYNCHRON C-REACTIVE PROTEIN REAGENT Beckman Instruments, Inc. | DCN |
| Mar 19, 1991 | K910686 | RHEUMAJET CRP Biokit USA, Inc., ES | DCN |
| Nov 1, 1990 | K904497 | CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST Biotrax, Inc. | DCN |
| Aug 30, 1990 | K903853 | RAPITEX (R) CRP NEW Behring Diagnostics, Inc. | DCN |
| Jun 28, 1990 | K902593 | RAICHEM(TM) SPIA(TM) CRP REAGENT Reagents Applications, Inc. | DCN |
| Nov 8, 1989 | K896272 | QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL Biokit USA, Inc., ES | DCN |
| Apr 21, 1989 | K892231 | V-TREND TARGET CRP TEST Texas Immunology, Inc. | DCN |
| Dec 20, 1988 | K885001 | QM300 PCR ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DCN |
| Sep 22, 1988 | K883515 | DU PONT DIMENSION C-REACTIVE PROTEIN METHOD E.I. Dupont DE Nemours & Co., Inc. | DCN |
| Jul 8, 1988 | K882374 | WAKO(TM) CRP Wako Chemicals USA, Inc. | DCN |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.