Product Code: DCK FDA class 2 21 CFR 866.5270

C-Reactive Protein, Antigen, Antiserum, And Control

Immunology

This is an immunological reagent kit for detecting and quantifying C-reactive protein (CRP), an acute-phase reactant protein synthesized by the liver in response to inflammation that is widely used as a clinical marker of infection, inflammatory disease, and cardiovascular risk. The kit includes antigen, antiserum, and control components for immunoassay testing. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DCK, regulated under 21 CFR 866.5270, within the Immunology specialty.

View on FDA

510(k)s

126

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DCK in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DCK
Device Class: FDA class 2
Regulation Number: 866.5270
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 126 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242170	K-ASSAY CRP (Ver.2)	Apr 18, 2025	Substantially Equivalent	Kamiya Biomedical Company, LLC
K201256	Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge	Nov 04, 2022	Substantially Equivalent	Procise Diagnostics
K192028	Yumizen C1200 CRP	Jun 25, 2020	Substantially Equivalent	HORIBA ABX SAS
K192118	CRP Vario	Nov 08, 2019	Substantially Equivalent	SENTINEL CH. SpA
K191993	Yumizen C1200 CRP	Oct 03, 2019	Substantially Equivalent	HORIBA ABX SAS
K160712	VITROS Chemistry Products hsCRP Reagent	Jul 14, 2017	Substantially Equivalent	Ortho Clinical Diagnostics
K142993	QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument	Mar 10, 2016	Substantially Equivalent	Orion Diagnostica, OY
K152433	VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7	Sep 24, 2015	Substantially Equivalent	Ortho Clinical Diagnostics
K141689	FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit	Jan 07, 2015	Substantially Equivalent	Qualigen, Inc.
K121558	DIAZYME HSCRP POC TEST KIT	Sep 21, 2012	Substantially Equivalent	Diazyme Laboratories
K103557	DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET	Apr 27, 2011	Substantially Equivalent	Diazyme Laboratories
K061138	ABX PENTRA 400 : CRP	Sep 29, 2006	Substantially Equivalent	Horiba Abx
K060139	CRP-ADVANCE ASSAY, MODELS 250-20, 250-25	Apr 28, 2006	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K052591	NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT	Feb 09, 2006	Substantially Equivalent	Clinical Data, Inc.
K050836	CRP DIAGNOSTIC ASSAY	Aug 08, 2005	Substantially Equivalent	Sentinel Ch. Srl
K041155	WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY	Oct 14, 2004	Substantially Equivalent	Stanbio Laboratory
K042442	QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE	Sep 24, 2004	Substantially Equivalent	Orion Diagnostica, OY
K040241	N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET	Jun 25, 2004	Substantially Equivalent	Genzyme Corp.
K040579	CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)	Jun 18, 2004	Substantially Equivalent	Cholestech Corp.
K032663	QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2	Dec 19, 2003	Substantially Equivalent	Instrumentation Laboratory CO
K031607	ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL	Oct 10, 2003	Substantially Equivalent	Orion Diagnostica, Div. Orion Corp.
K030044	EXTENDED RANGE HS CRP KIT, CAT NO:9200	Sep 30, 2003	Substantially Equivalent	Reference Diagnostics, Inc.
K024280	WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET	Jun 06, 2003	Substantially Equivalent	Wako Chemicals USA, Inc.
K030545	CRP-LATEX (II)X2 SEIKEN ASSAY KIT	Jun 02, 2003	Substantially Equivalent	Denka Seiken Co., Ltd.
K030626	VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7	Mar 18, 2003	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K023828	K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR	Feb 04, 2003	Substantially Equivalent	Kamiya Biomedical Co.
K023269	HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS	Dec 23, 2002	Substantially Equivalent	Instrumentation Laboratory CO
K022176	ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257	Dec 03, 2002	Substantially Equivalent	Orion Diagnostica, Div. Orion Corp.
K022486	K-ASSAY HS-CRP CONTROLS	Aug 14, 2002	Substantially Equivalent	Kamiya Biomedical Co.
K021194	RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM	Jul 29, 2002	Substantially Equivalent	Hemagen Diagnostics, Inc.
K021609	RDI HS CRP KIT	Jun 27, 2002	Substantially Equivalent	Reference Diagnostics, Inc.
K013787	NYCOCARD CRP	May 14, 2002	Substantially Equivalent	Primus Corp.
K014084	NYCOCARD CRP CONTROL	Jan 07, 2002	Substantially Equivalent	Primus Corp.
K003851	BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119	Jul 20, 2001	Substantially Equivalent	Biocheck, Inc.
K010597	SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT	May 29, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K011079	K-ASSAY HS-CRP CONTROLS	May 16, 2001	Substantially Equivalent	Kamiya Biomedical Co.
K010236	IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT	Apr 05, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K002558	K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE	Oct 25, 2000	Substantially Equivalent	Kamiya Biomedical Co.
K002651	C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET	Oct 13, 2000	Substantially Equivalent	Pointe Scientific, Inc.,
K001636	C-REACTIVE PROTEIN ANTISERUM KIT	Aug 24, 2000	Substantially Equivalent	The Binding Site, Ltd.
K001009	RANDOX C-REACTIVE PROTEIN	Aug 04, 2000	Substantially Equivalent	Randox Laboratories, Ltd.
K991385	DADE BEHRING N HIGH SENSITIVITY CRP ASSAY	Oct 25, 1999	Substantially Equivalent	Dade Behring, Inc.
K992312	K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B	Sep 13, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K992311	K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC	Sep 13, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K991224	K-ASSAY CRP	May 14, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K991210	K-ASSAY CRP CALIBRATOR SET	May 11, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K990704	ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT	May 03, 1999	Substantially Equivalent	Beckman Coulter, Inc.
K990886	IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5	Apr 06, 1999	Substantially Equivalent	Diagnostic Products Corp.
K984132	IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5	Jan 28, 1999	Substantially Equivalent	Diagnostic Products Corp.
K981871	C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100	Nov 09, 1998	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K982087	ROCHE CRP T CONTROL N	Aug 18, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K981638	IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT	Jun 12, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K973692	UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE	Feb 09, 1998	Substantially Equivalent	United Biotech, Inc.
K974050	SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT	Nov 24, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K972160	CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST	Aug 01, 1997	Substantially Equivalent	Trinity Laboratories, Inc.
K965110	N-ASSAY TIA MULTI CRP CALIBRATOR SET	Jul 03, 1997	Substantially Equivalent	Crestat Diagnostics, Inc.
K962049	C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT	Dec 18, 1996	Substantially Equivalent	Polymedco, Inc.
K962019	C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST	Nov 25, 1996	Substantially Equivalent	Teco Diagnostics
K963061	IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT	Nov 04, 1996	Substantially Equivalent	Beckman Instruments, Inc.
K961829	QUALITROL CRP CONTROL SET	Aug 19, 1996	Substantially Equivalent	Consolidated Technologies, Inc.
K962373	N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2	Jul 11, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K962523	N LATEX CRP MONO REAGENT	Jul 10, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K960702	CRP-LATEX SEIKEN XR REAGENT SYSTEM	Apr 19, 1996	Substantially Equivalent	Globe Management Support, Inc.
K960324	HEMAGEN CRP 150 KIT (EIA METHOD)	Mar 12, 1996	Substantially Equivalent	Hemagen Diagnostics, Inc.
K955156	WAKO AUTOKIT CRP NEW	Feb 16, 1996	Substantially Equivalent	Wako Chemicals USA, Inc.
K954447	C-REACTIVE PROTEIN LATEX KIT	Dec 18, 1995	Substantially Equivalent	Randox Laboratories, Ltd.
K953926	LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM	Sep 15, 1995	Substantially Equivalent	International Enzymes, Inc.
K953207	HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)	Aug 01, 1995	Substantially Equivalent	The Binding Site, Ltd.
K953212	C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR	Jul 31, 1995	Substantially Equivalent	Randox Laboratories, Ltd.
K953197	EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)	Jul 31, 1995	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K951057	MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2	Apr 20, 1995	Substantially Equivalent	Medical Analysis Systems, Inc.
K945280	DUPONT DIMENSION C-REACTIVE PROTEIN METHOD	Mar 09, 1995	Substantially Equivalent	Dupont Medical Products
K946050	LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2	Feb 10, 1995	Substantially Equivalent	Clinical Controls, Inc.
K944375	N/T RHEUMATOLOGY CONTROL SL/1, SL/2	Oct 03, 1994	Substantially Equivalent	Behring Diagnostics, Inc.
K944288	HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)	Oct 03, 1994	Substantially Equivalent	Hemagen Diagnostics, Inc.
K930621	TINA-QUANT CRP	Mar 10, 1993	Substantially Equivalent	Boehringer Mannheim Corp.
K924332	ACCUTEX CRP LATEX TEST	Dec 07, 1992	Substantially Equivalent	J.S. Medical Assoc.
K920845	VIGIL II	Dec 07, 1992	Substantially Equivalent	Beckman Instruments, Inc.
K923768	PULSE CRP TEST	Dec 01, 1992	Substantially Equivalent	Pulse Scientific, Inc.
K922722	TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL	Oct 05, 1992	Substantially Equivalent	Simplicity Diagnostics, Inc.
K914155	TIA CRP TEST KIT	Jan 15, 1992	Substantially Equivalent	Crestat Diagnostics, Inc.
K905633	HUMAN C-REACTIVE PROTEIN RID KIT	Jul 22, 1991	Substantially Equivalent	The Binding Site, Ltd.
K904312	RHEUMAGEN CRP T-CONTROL	Oct 01, 1990	Substantially Equivalent	Biokit USA, Inc.
K895598	WAKO(TM) AUTOKIT CRP	Sep 27, 1989	Substantially Equivalent	Wako Chemicals USA, Inc.
K894573	SCANLISA HUMAN CRP ELISA KIT	Aug 10, 1989	Substantially Equivalent	Immuntech A/S
K892526	SPQ TM TEST SYSTEM II FOR CRP	May 09, 1989	Substantially Equivalent	Atlantic Antibodies
K892198	TECHNICON DPA-1 (TM) CRP METHOD	May 09, 1989	Substantially Equivalent	Technicon Instruments Corp.
K892146	C REACTIVE PROTEIN LIQUID	Apr 14, 1989	Substantially Equivalent	Ampcor, Inc.
K892119	QUIK-DOT C REACTIVE PROTEIN	Apr 14, 1989	Substantially Equivalent	Ampcor, Inc.
K890423	V-TREND TARGET CRP TEST	Feb 17, 1989	Substantially Equivalent	Texas Immunology, Inc.
K884101	DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR	Oct 19, 1988	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K882998	ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST	Sep 07, 1988	Substantially Equivalent	Amtec Diagnostics International, Inc.
K880729	KALLESTAD QM300 CALIBRATOR C PACK	Mar 30, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K880730	KALLESTAD QM2/QM300 CONTROL C PACK	Mar 25, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K875345	VISION(R) CRP	Mar 21, 1988	Substantially Equivalent	Abbott Laboratories
K880016	MODIFIED CRP LATEX TEST	Feb 25, 1988	Substantially Equivalent	Sclavo, Inc.
K873865	CRP	Oct 13, 1987	Substantially Equivalent	Unipath , Ltd.
K871895	TINA-QUANT [A] CRP	Jun 15, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K871055	PRECIMAT(R) CRP	May 06, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K864131	VISION(TM) CRP	Mar 16, 1987	Substantially Equivalent	Abbott Laboratories
K863628	C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS	Oct 15, 1986	Substantially Equivalent	Technicon Instruments Corp.
K863329	ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR	Sep 26, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K863328	ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST	Sep 26, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K860550	DU PONT C-REACTIVE PROTEIN (CRP) ASSAY	Jun 10, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K860549	DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR	Jun 10, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K854542	TDX C-REACTIVE PROTEIN	Jan 24, 1986	Substantially Equivalent	Abbott Laboratories
K854221	DIESSE CRP TEST KIT	Nov 25, 1985	Substantially Equivalent	Marvic Interpharma, Inc.
K851842	SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN	Jun 05, 1985	Substantially Equivalent	Atlantic Antibodies
K850160	FISHER DIAGNOSTICS LATEST-CRP TEST KIT	Apr 19, 1985	Substantially Equivalent	Fisher Diagnostics
K850590	SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN	Mar 01, 1985	Substantially Equivalent	Applications Lab
K841862	IMMU-TEC	Jun 13, 1984	Substantially Equivalent	Medilab Corp.
K832054	FIAX CRP TEST KIT	Aug 26, 1983	Substantially Equivalent	Intl. Diagnostic Technology
K831958	RADIAL IMMUNO-TEST FOR HUMAN C-REACTI	Jul 19, 1983	Substantially Equivalent	Kent Laboratories, Inc.
K823417	PRISMA-C-REACTIVE PROTEIN CALIBRATORS	Dec 09, 1982	Substantially Equivalent	Syva Co.
K823416	PRISMA C-REACTIVE PROTEIN ASSAY	Dec 09, 1982	Substantially Equivalent	Syva Co.
K823415	PRISMA C-REACTIVE PROTEIN CONTROLS	Dec 09, 1982	Substantially Equivalent	Syva Co.
K822067	EMIT C-REACTIVE PROTEIN AUTOCAROUSEL	Jul 27, 1982	Substantially Equivalent	Syva Co.
K821984	QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.	Jul 22, 1982	Substantially Equivalent	Kallestad Laboratories, Inc.
K821412	C-REACTIVE PROTEIN CONTROL	Jul 22, 1982	Substantially Equivalent	Syva Co.
K811617	QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.	Jun 25, 1981	Substantially Equivalent	Kallestad Laboratories, Inc.
K791461	AGGLUTINOTEST-C-REACTIVE PROTEIN	Dec 31, 1979	Substantially Equivalent	Volu Sol Medical Industries
K792238	CRPTELL	Nov 30, 1979	Substantially Equivalent	Central Biological Co.
K791560	GOAT ANTI-HUMAN C-REACTIVE PROTEIN	Sep 24, 1979	Substantially Equivalent	Protos Laboratories
K791650	HUMAN, C-REACTIVE PROTEIN (CRP)	Sep 17, 1979	Substantially Equivalent	Beckman Instruments, Inc.
K760354	TEST, SLIDE FOR C-REATIVE PROTEIN	Aug 11, 1976	Substantially Equivalent	Icl Scientific
K760035	TEST, C-REATIVE PROTEIN, LATEX SLIDE	Aug 03, 1976	Substantially Equivalent	Gamma Biologicals, Inc.