DCK · Class II · 21 CFR 866.5270

FDA Product Code DCK: C-reactive Protein, Antigen, Antiserum, And Control

Leading manufacturers include Kamiya Biomedical Co., Syva Co. and E.I. Dupont DE Nemours & Co., Inc..

126
Total
126
Cleared
94d
Avg days
1976
Since
126 devices
25–48 of 126
Cleared Dec 23, 2002
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
K023269
Instrumentation Laboratory CO
Chemistry · 83d
Cleared Aug 14, 2002
K-ASSAY HS-CRP CONTROLS
K022486
Kamiya Biomedical Co.
Immunology · 16d
Cleared Jul 29, 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194
Hemagen Diagnostics, Inc.
Chemistry · 105d
Cleared Jun 27, 2002
RDI HS CRP KIT
K021609
Reference Diagnostics, Inc.
Chemistry · 42d
Cleared May 29, 2001
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
K010597
Beckman Coulter, Inc.
Chemistry · 90d
Cleared May 16, 2001
K-ASSAY HS-CRP CONTROLS
K011079
Kamiya Biomedical Co.
Immunology · 37d
Cleared Apr 05, 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236
Beckman Coulter, Inc.
Immunology · 70d
Cleared Oct 25, 2000
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
K002558
Kamiya Biomedical Co.
Immunology · 72d
Cleared Oct 13, 2000
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K002651
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Aug 24, 2000
C-REACTIVE PROTEIN ANTISERUM KIT
K001636
The Binding Site, Ltd.
Immunology · 86d
Cleared Aug 04, 2000
RANDOX C-REACTIVE PROTEIN
K001009
Randox Laboratories, Ltd.
Immunology · 128d
Cleared Oct 25, 1999
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
K991385
Dade Behring, Inc.
Immunology · 187d
Cleared Sep 13, 1999
K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC
K992311
Kamiya Biomedical Co.
Chemistry · 66d
Cleared Sep 13, 1999
K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
K992312
Kamiya Biomedical Co.
Immunology · 66d
Cleared May 14, 1999
K-ASSAY CRP
K991224
Kamiya Biomedical Co.
Immunology · 32d
Cleared May 11, 1999
K-ASSAY CRP CALIBRATOR SET
K991210
Kamiya Biomedical Co.
Immunology · 32d
Cleared May 03, 1999
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
K990704
Beckman Coulter, Inc.
Immunology · 60d
Cleared Apr 06, 1999
IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
K990886
Diagnostic Products Corp.
Immunology · 20d
Cleared Jan 28, 1999
IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
K984132
Diagnostic Products Corp.
Immunology · 71d
Cleared Nov 09, 1998
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
K981871
Diagnostic Systems Laboratories, Inc.
Immunology · 165d
Cleared Aug 18, 1998
ROCHE CRP T CONTROL N
K982087
Roche Diagnostic Systems, Inc.
Immunology · 64d
Cleared Jun 12, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K981638
Beckman Coulter, Inc.
Immunology · 35d
Cleared Feb 09, 1998
UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
K973692
United Biotech, Inc.
Immunology · 136d
Cleared Nov 24, 1997
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
K974050
Beckman Instruments, Inc.
Immunology · 31d