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 Olympus America, Inc..

70
Total
70
Cleared
94d
Avg days
1977
Since
70 devices
25–48 of 70
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 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 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 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 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