Product code DCK

Device name: C-Reactive Protein, Antigen, Antiserum, And Control
Medical specialty: Immunology
Device class: 2
Regulation number: 866.5270
Review panel: IM
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K242170	K-ASSAY CRP (Ver.2)	Kamiya Biomedical Company, LLC	2025-04-18
K201256	Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge	Procise Diagnostics	2022-11-04
K192028	Yumizen C1200 CRP	HORIBA ABX SAS	2020-06-25
K192118	CRP Vario	SENTINEL CH. SpA	2019-11-08
K191993	Yumizen C1200 CRP	HORIBA ABX SAS	2019-10-03
K160712	VITROS Chemistry Products hsCRP Reagent	Ortho Clinical Diagnostics	2017-07-14
K142993	QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument	Orion Diagnostica, OY	2016-03-10
K152433	VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7	Ortho Clinical Diagnostics	2015-09-24
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	Qualigen, Inc.	2015-01-07
K121558	DIAZYME HSCRP POC TEST KIT	Diazyme Laboratories	2012-09-21
K103557	DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET	Diazyme Laboratories	2011-04-27
K061138	ABX PENTRA 400 : CRP	Horiba Abx	2006-09-29
K060139	CRP-ADVANCE ASSAY, MODELS 250-20, 250-25	Diagnostic Chemicals , Ltd.	2006-04-28
K052591	NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT	Clinical Data, Inc.	2006-02-09
K050836	CRP DIAGNOSTIC ASSAY	Sentinel Ch. Srl	2005-08-08
K041155	WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY	Stanbio Laboratory	2004-10-14
K042442	QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE	Orion Diagnostica, OY	2004-09-24
K040241	N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET	Genzyme Corp.	2004-06-25
K040579	CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)	Cholestech Corp.	2004-06-18
K032663	QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2	Instrumentation Laboratory CO	2003-12-19
K031607	ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL	Orion Diagnostica, Div. Orion Corp.	2003-10-10
K030044	EXTENDED RANGE HS CRP KIT, CAT NO:9200	Reference Diagnostics, Inc.	2003-09-30
K024280	WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET	Wako Chemicals USA, Inc.	2003-06-06
K030545	CRP-LATEX (II)X2 SEIKEN ASSAY KIT	Denka Seiken Co., Ltd.	2003-06-02
K030626	VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7	Ortho-Clinical Diagnostics, Inc.	2003-03-18
K023828	K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR	Kamiya Biomedical Co.	2003-02-04
K023269	HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS	Instrumentation Laboratory CO	2002-12-23
K022176	ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257	Orion Diagnostica, Div. Orion Corp.	2002-12-03
K022486	K-ASSAY HS-CRP CONTROLS	Kamiya Biomedical Co.	2002-08-14
K021194	RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM	Hemagen Diagnostics, Inc.	2002-07-29

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00816426021549	K-ASSAY® CRP Reagent (Ver.2)	KAMIYA BIOMEDICAL COMPANY, LLC	2026-02-27
00816426021556	K-ASSAY® CRP Calibrator (Ver.2)	KAMIYA BIOMEDICAL COMPANY, LLC	2026-02-27
08100322954295	ProciseDx Calibration Cartridge	Chembio Diagnostic Systems Inc.	2024-08-06
08100322943909	ProciseDx Analyzer	Chembio Diagnostic Systems Inc.	2024-08-05
10673486002430	Teco Diagnostics C-Reactive Protein (CRP) Reagent Set	TECO DIAGNOSTICS	2024-04-02
04048474039542	C-Reactive Protein HS ELISA	DRG Instruments Gesellschaft mit beschränkter Haftung	2023-08-31
00811727015815	Pointe CRP Reagent	HORIBA INSTRUMENTS INCORPORATED	2021-01-30
00811727016126	Pointe CRP Reagent	HORIBA INSTRUMENTS INCORPORATED	2021-01-30
03610230007297	Yumizen C1200 CRP	HORIBA ABX SAS	2020-07-13
00083059070330	HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT	BIOMERICA, INC.	2020-07-01
10758750006915	VITROS	ORTHO-CLINICAL DIAGNOSTICS, INC.	2020-05-16
10758750001637	VITROS	ORTHO-CLINICAL DIAGNOSTICS, INC.	2020-05-16
10758750001965	VITROS	ORTHO-CLINICAL DIAGNOSTICS, INC.	2020-05-16
00380740180331	Alinity	ABBOTT LABORATORIES	2020-01-13
08058056681911	CRP Ultra (MP)	SENTINEL CH. SPA	2018-02-27
00630414596198	Atellica CH CRP_2	Siemens Healthcare Diagnostics Inc.	2017-12-27
08305900070330	HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT	BIOMERICA, INC.	2016-12-07
08426950590460	CRP Titer Control	BIOKIT, S.A.	2016-09-23
04015630915316	CRP T Control N	Roche Diagnostics GmbH	2016-09-20
00380740010461	ARCHITECT	ABBOTT LABORATORIES	2016-09-09
00380740010492	ARCHITECT	ABBOTT LABORATORIES	2016-09-09
00380740010485	ARCHITECT	ABBOTT LABORATORIES	2016-09-09
00380740010478	ARCHITECT	ABBOTT LABORATORIES	2016-09-09
00380740010447	ARCHITECT	ABBOTT LABORATORIES	2016-09-09
10758750004355	VITROS	ORTHO-CLINICAL DIAGNOSTICS, INC.	2016-08-26
10758750000296	VITROS	ORTHO-CLINICAL DIAGNOSTICS, INC.	2016-08-23
03610230005477	ABX PENTRA LOW CRP CONTROL	HORIBA ABX SAS	2016-08-23
03610230004760	ABX CRP REA	HORIBA ABX SAS	2016-08-23
03610230004791	ABX PENTRA CRP CP	HORIBA ABX SAS	2016-08-16
03610230004487	ABX CRP 100	HORIBA ABX SAS	2016-08-16

Product code DCK

Related 510(k) Records#

Related GUDID Devices#