Atlas FDA

DCN

70 FDA 510(k) clearances · Product code

70 daysmedian time to decision
234 days90th percentile
70clearances measured

FDA profile

Official device name
System, Test, C-Reactive Protein
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5270
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 2 · 2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CardioPhase® hsCRP (K232624)Siemens Healthcare Diagnostic Products GmbH2023-11-27
RCRP Flex reagent cartridge (K221119)Siemens Healthcare Diagnostics, Inc.2023-03-17
Tina-quant C-Reactive Protein IV (K192072)Roche Diagnostics Operations (Rdo)2020-02-21
Optilite High Sensitivity C-Reactive Protein Kit (K180099)The Binding Site Group , Ltd.2018-10-12
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls (K172868)The Binding Site Group , Ltd.2018-02-28
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (K171498)Meso Scale Diagnostics, LLC2018-01-12
C-Reactive Protein Kit for use on SPAPLUS (K161982)The Binding Site Group2017-04-05
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (K113809)Hitachi Chemical Diagnostics, Inc.2012-08-17
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (K091052)Abaxis, Inc.2010-01-15
C-REACTIVE PROTEIN (LATEX) (K083444)Roche Diagnostics Corp.2009-03-18
PATHFAST HSCRP (K083412)Mitsubishi Kagaku Iatron2009-03-09
S-TEST C-REACTIVE PROTEIN (CRP) (K083040)Alfa Wassermann Diagnostic Technologies, Inc.2009-01-30
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS (K072658)Siemens Medical Solutions Diagnostics2008-04-01
ROCHE-CREACTIVE PROTEIN (LATEX) (K073277)Roche Diagnostics Corp.2008-03-06
I-CHROMA CRP TEST (K062981)Boditech Diagnostics, Inc.2007-07-13
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH (K061825)Dade Behring, Inc.2006-09-06
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 (K050713)Good Biotech Corp.2005-06-06
BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 (K040030)Biocheck, Inc.2004-06-16
TINA-QUANT CRP (LATEX) (K032336)Roche Diagnostics Corp.2003-08-05
C-REACTIVE PROTEIN (CRP) (K030899)Abbott Laboratories2003-07-02
PAROS CRP (K022690)Horiba, Ltd.2002-12-23
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET (K021757)Good Biotech Corp.2002-07-29
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR (K021572)Beckman Coulter, Inc.2002-07-19
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 (K021882)Good Biotech Corp.2002-07-11
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 (K020603)Good Biotech Corp.2002-06-13
WAMPOLE HS-CRP ELISA (K011855)Carter-Wallace, Inc.2002-01-08
BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM (K012337)Bayer Corp.2001-12-06
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT (K011958)Denka Seiken'S2001-12-04
CRP HS TEST SYSTEM (K003400)Roche Diagnostics Corp.2001-05-10
RCRP FLEX REAGENT CARTRIDGE (K003419)Dade Behring, Inc.2001-02-14
WAKO CRP-UL, CRP-UL CALIBRATOR SET (K003342)Wako Chemicals USA, Inc.2001-01-22
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP (K003372)Diagnostic Products Corp.2000-12-26
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT (K002918)Olympus America, Inc.2000-10-25
CRP (K991372)Abbott Laboratories1999-06-01
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE (K990825)Dade Behring, Inc.1999-04-16
RAPET CRP (K974429)Stanbio Laboratory1998-02-18
OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT (K954537)Olympus America, Inc.1996-02-14
CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM (K955042)Shared Systems, Inc.1995-12-13
SPQ CRP CONTROL LEVEL II (K935075)Incstar Corp.1994-01-11
EYE SPOT CRP TEST (K932180)J.S. Medical Assoc.1993-08-23
SYNCHRON C-REACTIVE PROTEIN REAGENT (K910535)Beckman Instruments, Inc.1991-04-12
RHEUMAJET CRP (K910686)Biokit USA, Inc.1991-03-19
CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST (K904497)Biotrax, Inc.1990-11-01
RAPITEX (R) CRP NEW (K903853)Behring Diagnostics, Inc.1990-08-30
RAICHEM(TM) SPIA(TM) CRP REAGENT (K902593)Reagents Applications, Inc.1990-06-28
QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL (K896272)Biokit USA, Inc.1989-11-08
V-TREND TARGET CRP TEST (K892231)Texas Immunology, Inc.1989-04-21
QM300 PCR ANTIBODY PACK (K885001)Kallestad Diag, A Div. of Erbamont, Inc.1988-12-20
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD (K883515)E.I. Dupont DE Nemours & Co., Inc.1988-09-22
WAKO(TM) CRP (K882374)Wako Chemicals USA, Inc.1988-07-08
KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK (K880728)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-25
EUROGENETICS CRP ELISA (K872539)Eurogenetics1987-10-20
IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN (K860679)Orion Corp.1986-08-04
CPR SLIDE EIKEN (K854819)Syn-Kit, Inc.1986-02-26
LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) (K855057)Behring Diagnostics, Inc.1986-02-26
TAGO DIFFU-GEN C-REACTIVE PROTEIN (K841265)Tago, Inc.1984-05-22
CRP SLIDE TEST KIT (K840699)Difco Laboratories, Inc.1984-03-23
NABI CRP-Q.S. TEST (K834584)Intl. Diagnostic, Inc.1984-02-27
IMMUNO-CRP (K834390)Immunostics Co., Inc.1984-02-03
CRP-CHECK (K831465)Diagnostic Technology, Inc.1983-06-08
TESTCORP CRP (K831362)Catheter Technology Corp.1983-05-27
TESTCORP RA (K831364)Myo-Tronics Research, Inc.1983-05-27
SERO/TEX CRP TEST (K821388)Texas Immunology, Inc.1982-07-02
EMIT C-REACTIVE PROTEIN ASSAY (K821413)Syva Co.1982-05-28
IMMUNEX CRP (K812881)Armkel, LLC1981-10-26
BI-CRP LATEX TEST (K811374)Biologics Intl., Inc.1981-06-12
CRP SLIDE (K810862)Syn-Kit, Inc.1981-04-08
ANTISERUM TO HUMAN C-REACTIVE PROTEINS (K790716)Kent Laboratories, Inc.1979-08-03
LAS-R HUMAN CRP TEST (K771535)Hyland Therapeutic Div., Travenol Laboratories1977-09-02
CRP-WELLCOTEST (K771139)Burroughs Wellcome Co.1977-07-14

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