Atlas FDA

DCK

126 FDA 510(k) clearances · Product code

63 daysmedian time to decision
187 days90th percentile
126clearances measured

FDA profile

Official device name
C-Reactive Protein, Antigen, Antiserum, And Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5270
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
K-ASSAY CRP (Ver.2) (K242170)Kamiya Biomedical Company, LLC2025-04-18
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge (K201256)Procise Diagnostics2022-11-04
Yumizen C1200 CRP (K192028)HORIBA ABX SAS2020-06-25
CRP Vario (K192118)SENTINEL CH. SpA2019-11-08
Yumizen C1200 CRP (K191993)HORIBA ABX SAS2019-10-03
VITROS Chemistry Products hsCRP Reagent (K160712)Ortho Clinical Diagnostics2017-07-14
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument (K142993)Orion Diagnostica, OY2016-03-10
VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (K152433)Ortho Clinical Diagnostics2015-09-24
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 (K141689)Qualigen, Inc.2015-01-07
DIAZYME HSCRP POC TEST KIT (K121558)Diazyme Laboratories2012-09-21
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET (K103557)Diazyme Laboratories2011-04-27
ABX PENTRA 400 : CRP (K061138)Horiba Abx2006-09-29
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 (K060139)Diagnostic Chemicals , Ltd.2006-04-28
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT (K052591)Clinical Data, Inc.2006-02-09
CRP DIAGNOSTIC ASSAY (K050836)Sentinel Ch. Srl2005-08-08
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY (K041155)Stanbio Laboratory2004-10-14
QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE (K042442)Orion Diagnostica, OY2004-09-24
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET (K040241)Genzyme Corp.2004-06-25
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) (K040579)Cholestech Corp.2004-06-18
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 (K032663)Instrumentation Laboratory CO2003-12-19
ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL (K031607)Orion Diagnostica, Div. Orion Corp.2003-10-10
EXTENDED RANGE HS CRP KIT, CAT NO:9200 (K030044)Reference Diagnostics, Inc.2003-09-30
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET (K024280)Wako Chemicals USA, Inc.2003-06-06
CRP-LATEX (II)X2 SEIKEN ASSAY KIT (K030545)Denka Seiken Co., Ltd.2003-06-02
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 (K030626)Ortho-Clinical Diagnostics, Inc.2003-03-18
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR (K023828)Kamiya Biomedical Co.2003-02-04
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS (K023269)Instrumentation Laboratory CO2002-12-23
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 (K022176)Orion Diagnostica, Div. Orion Corp.2002-12-03
K-ASSAY HS-CRP CONTROLS (K022486)Kamiya Biomedical Co.2002-08-14
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM (K021194)Hemagen Diagnostics, Inc.2002-07-29
RDI HS CRP KIT (K021609)Reference Diagnostics, Inc.2002-06-27
NYCOCARD CRP (K013787)Primus Corp.2002-05-14
NYCOCARD CRP CONTROL (K014084)Primus Corp.2002-01-07
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 (K003851)Biocheck, Inc.2001-07-20
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT (K010597)Beckman Coulter, Inc.2001-05-29
K-ASSAY HS-CRP CONTROLS (K011079)Kamiya Biomedical Co.2001-05-16
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT (K010236)Beckman Coulter, Inc.2001-04-05
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE (K002558)Kamiya Biomedical Co.2000-10-25
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET (K002651)Pointe Scientific, Inc.,2000-10-13
C-REACTIVE PROTEIN ANTISERUM KIT (K001636)The Binding Site, Ltd.2000-08-24
RANDOX C-REACTIVE PROTEIN (K001009)Randox Laboratories, Ltd.2000-08-04
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY (K991385)Dade Behring, Inc.1999-10-25
K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC (K992311)Kamiya Biomedical Co.1999-09-13
K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B (K992312)Kamiya Biomedical Co.1999-09-13
K-ASSAY CRP (K991224)Kamiya Biomedical Co.1999-05-14
K-ASSAY CRP CALIBRATOR SET (K991210)Kamiya Biomedical Co.1999-05-11
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT (K990704)Beckman Coulter, Inc.1999-05-03
IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 (K990886)Diagnostic Products Corp.1999-04-06
IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5 (K984132)Diagnostic Products Corp.1999-01-28
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 (K981871)Diagnostic Systems Laboratories, Inc.1998-11-09
ROCHE CRP T CONTROL N (K982087)Roche Diagnostic Systems, Inc.1998-08-18
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT (K981638)Beckman Coulter, Inc.1998-06-12
UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE (K973692)United Biotech, Inc.1998-02-09
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT (K974050)Beckman Instruments, Inc.1997-11-24
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST (K972160)Trinity Laboratories, Inc.1997-08-01
N-ASSAY TIA MULTI CRP CALIBRATOR SET (K965110)Crestat Diagnostics, Inc.1997-07-03
C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT (K962049)Polymedco, Inc.1996-12-18
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST (K962019)Teco Diagnostics1996-11-25
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT (K963061)Beckman Instruments, Inc.1996-11-04
QUALITROL CRP CONTROL SET (K961829)Consolidated Technologies, Inc.1996-08-19
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 (K962373)Behring Diagnostics, Inc.1996-07-11
N LATEX CRP MONO REAGENT (K962523)Behring Diagnostics, Inc.1996-07-10
CRP-LATEX SEIKEN XR REAGENT SYSTEM (K960702)Globe Management Support, Inc.1996-04-19
HEMAGEN CRP 150 KIT (EIA METHOD) (K960324)Hemagen Diagnostics, Inc.1996-03-12
WAKO AUTOKIT CRP NEW (K955156)Wako Chemicals USA, Inc.1996-02-16
C-REACTIVE PROTEIN LATEX KIT (K954447)Randox Laboratories, Ltd.1995-12-18
LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM (K953926)International Enzymes, Inc.1995-09-15
HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) (K953207)The Binding Site, Ltd.1995-08-01
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) (K953197)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-31
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR (K953212)Randox Laboratories, Ltd.1995-07-31
MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2 (K951057)Medical Analysis Systems, Inc.1995-04-20
DUPONT DIMENSION C-REACTIVE PROTEIN METHOD (K945280)Dupont Medical Products1995-03-09
LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 (K946050)Clinical Controls, Inc.1995-02-10
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) (K944288)Hemagen Diagnostics, Inc.1994-10-03
N/T RHEUMATOLOGY CONTROL SL/1, SL/2 (K944375)Behring Diagnostics, Inc.1994-10-03
TINA-QUANT CRP (K930621)Boehringer Mannheim Corp.1993-03-10
ACCUTEX CRP LATEX TEST (K924332)J.S. Medical Assoc.1992-12-07
VIGIL II (K920845)Beckman Instruments, Inc.1992-12-07
PULSE CRP TEST (K923768)Pulse Scientific, Inc.1992-12-01
TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL (K922722)Simplicity Diagnostics, Inc.1992-10-05
TIA CRP TEST KIT (K914155)Crestat Diagnostics, Inc.1992-01-15
HUMAN C-REACTIVE PROTEIN RID KIT (K905633)The Binding Site, Ltd.1991-07-22
RHEUMAGEN CRP T-CONTROL (K904312)Biokit USA, Inc.1990-10-01
WAKO(TM) AUTOKIT CRP (K895598)Wako Chemicals USA, Inc.1989-09-27
SCANLISA HUMAN CRP ELISA KIT (K894573)Immuntech A/S1989-08-10
SPQ TM TEST SYSTEM II FOR CRP (K892526)Atlantic Antibodies1989-05-09
TECHNICON DPA-1 (TM) CRP METHOD (K892198)Technicon Instruments Corp.1989-05-09
C REACTIVE PROTEIN LIQUID (K892146)Ampcor, Inc.1989-04-14
QUIK-DOT C REACTIVE PROTEIN (K892119)Ampcor, Inc.1989-04-14
V-TREND TARGET CRP TEST (K890423)Texas Immunology, Inc.1989-02-17
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR (K884101)E.I. Dupont DE Nemours & Co., Inc.1988-10-19
ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST (K882998)Amtec Diagnostics International, Inc.1988-09-07
KALLESTAD QM300 CALIBRATOR C PACK (K880729)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-30
KALLESTAD QM2/QM300 CONTROL C PACK (K880730)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-25
VISION(R) CRP (K875345)Abbott Laboratories1988-03-21
MODIFIED CRP LATEX TEST (K880016)Sclavo, Inc.1988-02-25
CRP (K873865)Unipath , Ltd.1987-10-13
TINA-QUANT [A] CRP (K871895)Boehringer Mannheim Corp.1987-06-15
PRECIMAT(R) CRP (K871055)Boehringer Mannheim Corp.1987-05-06
VISION(TM) CRP (K864131)Abbott Laboratories1987-03-16
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