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 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 Nov 24, 1997
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
K974050
Beckman Instruments, Inc.
Immunology · 31d
Cleared Aug 01, 1997
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
K972160
Trinity Laboratories, Inc.
Immunology · 53d
Cleared Nov 25, 1996
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
K962019
Teco Diagnostics
Immunology · 186d
Cleared Nov 04, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K963061
Beckman Instruments, Inc.
Immunology · 89d
Cleared Jul 11, 1996
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
K962373
Behring Diagnostics, Inc.
Immunology · 21d
Cleared Jul 10, 1996
N LATEX CRP MONO REAGENT
K962523
Behring Diagnostics, Inc.
Immunology · 41d
Cleared Mar 12, 1996
HEMAGEN CRP 150 KIT (EIA METHOD)
K960324
Hemagen Diagnostics, Inc.
Immunology · 49d
Cleared Feb 16, 1996
WAKO AUTOKIT CRP NEW
K955156
Wako Chemicals USA, Inc.
Immunology · 95d
Cleared Dec 18, 1995
C-REACTIVE PROTEIN LATEX KIT
K954447
Randox Laboratories, Ltd.
Immunology · 84d
Cleared Aug 01, 1995
HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)
K953207
The Binding Site, Ltd.
Immunology · 63d
Cleared Jul 31, 1995
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
K953212
Randox Laboratories, Ltd.
Immunology · 21d