Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

System, Test, C-Reactive Protein

FDA product code DCN · 70 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5270
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-07-14 – 2023-11-27

DCN 2023-11-27

CardioPhase® hsCRP

Applicant Siemens Healthcare Diagnostic Products GmbH

K number K232624

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DCN 2023-03-17

RCRP Flex reagent cartridge

Applicant Siemens Healthcare Diagnostics, Inc.

K number K221119

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DCN 2020-02-21

Tina-quant C-Reactive Protein IV

Applicant Roche Diagnostics Operations (Rdo)

K number K192072

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DCN 2018-10-12

Optilite High Sensitivity C-Reactive Protein Kit

Applicant The Binding Site Group , Ltd.

K number K180099

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DCN 2018-02-28

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

Applicant The Binding Site Group , Ltd.

K number K172868

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DCN 2018-01-12

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument

Applicant Meso Scale Diagnostics, LLC

K number K171498

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DCN 2017-04-05

C-Reactive Protein Kit for use on SPAPLUS

Applicant The Binding Site Group

K number K161982

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DCN 2012-08-17

HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)

Applicant Hitachi Chemical Diagnostics, Inc.

K number K113809

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DCN 2010-01-15

PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM

Applicant Abaxis, Inc.

K number K091052

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DCN 2009-03-18

C-REACTIVE PROTEIN (LATEX)

Applicant Roche Diagnostics Corp.

K number K083444

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DCN 2009-03-09

PATHFAST HSCRP

Applicant Mitsubishi Kagaku Iatron

K number K083412

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DCN 2009-01-30

S-TEST C-REACTIVE PROTEIN (CRP)

Applicant Alfa Wassermann Diagnostic Technologies, Inc.

K number K083040

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DCN 2008-04-01

ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS

Applicant Siemens Medical Solutions Diagnostics

K number K072658

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DCN 2008-03-06

ROCHE-CREACTIVE PROTEIN (LATEX)

Applicant Roche Diagnostics Corp.

K number K073277

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DCN 2007-07-13

I-CHROMA CRP TEST

Applicant Boditech Diagnostics, Inc.

K number K062981

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DCN 2006-09-06

DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH

Applicant Dade Behring, Inc.

K number K061825

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DCN 2005-06-06

DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511

Applicant Good Biotech Corp.

K number K050713

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DCN 2004-06-16

BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114

Applicant Biocheck, Inc.

K number K040030

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DCN 2003-08-05

TINA-QUANT CRP (LATEX)

Applicant Roche Diagnostics Corp.

K number K032336

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DCN 2003-07-02

C-REACTIVE PROTEIN (CRP)

Applicant Abbott Laboratories

K number K030899

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DCN 2002-12-23

PAROS CRP

Applicant Horiba, Ltd.

K number K022690

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DCN 2002-07-29

CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET

Applicant Good Biotech Corp.

K number K021757

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DCN 2002-07-19

SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR

Applicant Beckman Coulter, Inc.

K number K021572

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DCN 2002-07-11

CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510

Applicant Good Biotech Corp.

K number K021882

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DCN 2002-06-13

CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010

Applicant Good Biotech Corp.

K number K020603

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DCN 2002-01-08

WAMPOLE HS-CRP ELISA

Applicant Carter-Wallace, Inc.

K number K011855

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DCN 2001-12-06

BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM

Applicant Bayer Corp.

K number K012337

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DCN 2001-12-04

CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT

Applicant Denka Seiken'S

K number K011958

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DCN 2001-05-10

CRP HS TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K003400

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DCN 2001-02-14

RCRP FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K003419

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DCN 2001-01-22

WAKO CRP-UL, CRP-UL CALIBRATOR SET

Applicant Wako Chemicals USA, Inc.

K number K003342

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DCN 2000-12-26

IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP

Applicant Diagnostic Products Corp.

K number K003372

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DCN 2000-10-25

OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT

Applicant Olympus America, Inc.

K number K002918

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DCN 1999-06-01

CRP

Applicant Abbott Laboratories

K number K991372

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DCN 1999-04-16

REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K990825

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DCN 1998-02-18

RAPET CRP

Applicant Stanbio Laboratory

K number K974429

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DCN 1996-02-14

OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT

Applicant Olympus America, Inc.

K number K954537

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DCN 1995-12-13

CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM

Applicant Shared Systems, Inc.

K number K955042

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DCN 1994-01-11

SPQ CRP CONTROL LEVEL II

Applicant Incstar Corp.

K number K935075

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DCN 1993-08-23

EYE SPOT CRP TEST

Applicant J.S. Medical Assoc.

K number K932180

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DCN 1991-04-12

SYNCHRON C-REACTIVE PROTEIN REAGENT

Applicant Beckman Instruments, Inc.

K number K910535

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DCN 1991-03-19

RHEUMAJET CRP

Applicant Biokit USA, Inc.

K number K910686

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DCN 1990-11-01

CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST

Applicant Biotrax, Inc.

K number K904497

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DCN 1990-08-30

RAPITEX (R) CRP NEW

Applicant Behring Diagnostics, Inc.

K number K903853

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DCN 1990-06-28

RAICHEM(TM) SPIA(TM) CRP REAGENT

Applicant Reagents Applications, Inc.

K number K902593

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DCN 1989-11-08

QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL

Applicant Biokit USA, Inc.

K number K896272

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DCN 1989-04-21

V-TREND TARGET CRP TEST

Applicant Texas Immunology, Inc.

K number K892231

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DCN 1988-12-20

QM300 PCR ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K885001

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DCN 1988-09-22

DU PONT DIMENSION C-REACTIVE PROTEIN METHOD

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K883515

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DCN 1988-07-08

WAKO(TM) CRP

Applicant Wako Chemicals USA, Inc.

K number K882374

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DCN 1988-03-25

KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K880728

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DCN 1987-10-20

EUROGENETICS CRP ELISA

Applicant Eurogenetics

K number K872539

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DCN 1986-08-04

IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN

Applicant Orion Corp.

K number K860679

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DCN 1986-02-26

LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)

Applicant Behring Diagnostics, Inc.

K number K855057

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DCN 1986-02-26

CPR SLIDE EIKEN

Applicant Syn-Kit, Inc.

K number K854819

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DCN 1984-05-22

TAGO DIFFU-GEN C-REACTIVE PROTEIN

Applicant Tago, Inc.

K number K841265

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DCN 1984-03-23

CRP SLIDE TEST KIT

Applicant Difco Laboratories, Inc.

K number K840699

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DCN 1984-02-27

NABI CRP-Q.S. TEST

Applicant Intl. Diagnostic, Inc.

K number K834584

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DCN 1984-02-03

IMMUNO-CRP

Applicant Immunostics Co., Inc.

K number K834390

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DCN 1983-06-08

CRP-CHECK

Applicant Diagnostic Technology, Inc.

K number K831465

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DCN 1983-05-27

TESTCORP RA

Applicant Myo-Tronics Research, Inc.

K number K831364

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DCN 1983-05-27

TESTCORP CRP

Applicant Catheter Technology Corp.

K number K831362

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DCN 1982-07-02

SERO/TEX CRP TEST

Applicant Texas Immunology, Inc.

K number K821388

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DCN 1982-05-28

EMIT C-REACTIVE PROTEIN ASSAY

Applicant Syva Co.

K number K821413

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DCN 1981-10-26

IMMUNEX CRP

Applicant Armkel, LLC

K number K812881

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DCN 1981-06-12

BI-CRP LATEX TEST

Applicant Biologics Intl., Inc.

K number K811374

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DCN 1981-04-08

CRP SLIDE

Applicant Syn-Kit, Inc.

K number K810862

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DCN 1979-08-03

ANTISERUM TO HUMAN C-REACTIVE PROTEINS

Applicant Kent Laboratories, Inc.

K number K790716

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DCN 1977-09-02

LAS-R HUMAN CRP TEST

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K771535

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DCN 1977-07-14

CRP-WELLCOTEST

Applicant Burroughs Wellcome Co.

K number K771139

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