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
49–72 of 126
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 Jul 03, 1997
N-ASSAY TIA MULTI CRP CALIBRATOR SET
K965110
Crestat Diagnostics, Inc.
Immunology · 195d
Cleared Dec 18, 1996
C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT
K962049
Polymedco, Inc.
Immunology · 204d
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 Aug 19, 1996
QUALITROL CRP CONTROL SET
K961829
Consolidated Technologies, Inc.
Immunology · 98d
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 Apr 19, 1996
CRP-LATEX SEIKEN XR REAGENT SYSTEM
K960702
Globe Management Support, Inc.
Immunology · 59d
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
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)
K953197
Johnson & Johnson Clinical Diagnostics, Inc.
Immunology · 21d
Cleared Jul 31, 1995
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
K953212
Randox Laboratories, Ltd.
Immunology · 21d
Cleared Apr 20, 1995
MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2
K951057
Medical Analysis Systems, Inc.
Immunology · 44d
Cleared Mar 09, 1995
DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
K945280
Dupont Medical Products
Immunology · 132d
Cleared Feb 10, 1995
LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2
K946050
Clinical Controls, Inc.
Immunology · 60d
Cleared Oct 03, 1994
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)
K944288
Hemagen Diagnostics, Inc.
Immunology · 31d
Cleared Oct 03, 1994
N/T RHEUMATOLOGY CONTROL SL/1, SL/2
K944375
Behring Diagnostics, Inc.
Immunology · 26d
Cleared Mar 10, 1993
TINA-QUANT CRP
K930621
Boehringer Mannheim Corp.
Immunology · 30d
Cleared Dec 07, 1992
VIGIL II
K920845
Beckman Instruments, Inc.
Microbiology · 286d
Cleared Dec 07, 1992
ACCUTEX CRP LATEX TEST
K924332
J.S. Medical Assoc.
Immunology · 102d
Cleared Jan 15, 1992
TIA CRP TEST KIT
K914155
Crestat Diagnostics, Inc.
Immunology · 121d