DCN · Class II · 21 CFR 866.5270

FDA Product Code DCN: System, Test, C-reactive Protein

Leading manufacturers include Roche Diagnostics Corp., Dade Behring, Inc. and The Binding Site Group , Ltd..

70
Total
70
Cleared
94d
Avg days
1977
Since
70 devices
25–48 of 70
Cleared Apr 16, 1999
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
K990825
Dade Behring, Inc.
Immunology · 35d
Cleared Feb 18, 1998
RAPET CRP
K974429
Stanbio Laboratory
Immunology · 86d
Cleared Feb 14, 1996
OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
K954537
Olympus America, Inc.
Immunology · 138d
Cleared Jan 11, 1994
SPQ CRP CONTROL LEVEL II
K935075
Incstar Corp.
Immunology · 78d
Cleared Aug 23, 1993
EYE SPOT CRP TEST
K932180
J.S. Medical Assoc.
Immunology · 110d
Cleared Apr 12, 1991
SYNCHRON C-REACTIVE PROTEIN REAGENT
K910535
Beckman Instruments, Inc.
Immunology · 63d
Cleared Aug 30, 1990
RAPITEX (R) CRP NEW
K903853
Behring Diagnostics, Inc.
Immunology · 9d
Cleared Jun 28, 1990
RAICHEM(TM) SPIA(TM) CRP REAGENT
K902593
Reagents Applications, Inc.
Immunology · 16d
Cleared Apr 21, 1989
V-TREND TARGET CRP TEST
K892231
Texas Immunology, Inc.
Immunology · 17d
Cleared Dec 20, 1988
QM300 PCR ANTIBODY PACK
K885001
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Sep 22, 1988
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
K883515
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 36d
Cleared Jul 08, 1988
WAKO(TM) CRP
K882374
Wako Chemicals USA, Inc.
Immunology · 29d
Cleared Mar 25, 1988
KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK
K880728
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 31d
Cleared Aug 04, 1986
IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN
K860679
Orion Corp.
Immunology · 160d
Cleared Feb 26, 1986
CPR SLIDE EIKEN
K854819
Syn-Kit, Inc.
Immunology · 85d
Cleared Feb 26, 1986
LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)
K855057
Behring Diagnostics, Inc.
Immunology · 70d
Cleared Mar 23, 1984
CRP SLIDE TEST KIT
K840699
Difco Laboratories, Inc.
Immunology · 36d
Cleared Jun 08, 1983
CRP-CHECK
K831465
Diagnostic Technology, Inc.
Immunology · 33d
Cleared Jul 02, 1982
SERO/TEX CRP TEST
K821388
Texas Immunology, Inc.
Immunology · 53d
Cleared May 28, 1982
EMIT C-REACTIVE PROTEIN ASSAY
K821413
Syva Co.
Immunology · 16d
Cleared Oct 26, 1981
IMMUNEX CRP
K812881
Armkel, LLC
Immunology · 12d
Cleared Apr 08, 1981
CRP SLIDE
K810862
Syn-Kit, Inc.
Immunology · 8d
Cleared Aug 03, 1979
ANTISERUM TO HUMAN C-REACTIVE PROTEINS
K790716
Kent Laboratories, Inc.
Immunology · 113d
Cleared Sep 02, 1977
LAS-R HUMAN CRP TEST
K771535
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 23d