DCN · Class II · 21 CFR 866.5270

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

Leading manufacturers include Roche Diagnostics Corp., Good Biotech Corp. and Dade Behring, Inc..

70
Total
70
Cleared
94d
Avg days
1977
Since
70 devices
49–70 of 70
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 Oct 20, 1987
EUROGENETICS CRP ELISA
K872539
Eurogenetics
Immunology · 113d
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 May 22, 1984
TAGO DIFFU-GEN C-REACTIVE PROTEIN
K841265
Tago, Inc.
Chemistry · 57d
Cleared Mar 23, 1984
CRP SLIDE TEST KIT
K840699
Difco Laboratories, Inc.
Immunology · 36d
Cleared Feb 27, 1984
NABI CRP-Q.S. TEST
K834584
Intl. Diagnostic, Inc.
Immunology · 60d
Cleared Feb 03, 1984
IMMUNO-CRP
K834390
Immunostics Co., Inc.
Microbiology · 51d
Cleared Jun 08, 1983
CRP-CHECK
K831465
Diagnostic Technology, Inc.
Immunology · 33d
Cleared May 27, 1983
TESTCORP CRP
K831362
Catheter Technology Corp.
Microbiology · 31d
Cleared May 27, 1983
TESTCORP RA
K831364
Myo-Tronics Research, Inc.
Microbiology · 31d
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 Jun 12, 1981
BI-CRP LATEX TEST
K811374
Biologics Intl., Inc.
Microbiology · 28d
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
Cleared Jul 14, 1977
CRP-WELLCOTEST
K771139
Burroughs Wellcome Co.
Immunology · 17d