DCK · Class II · 21 CFR 866.5270

FDA Product Code DCK: C-reactive Protein, Antigen, Antiserum, And Control

Leading manufacturers include Kamiya Biomedical Co., E.I. Dupont DE Nemours & Co., Inc. and Syva Co..

126
Total
126
Cleared
94d
Avg days
1976
Since
126 devices
97–120 of 126
Cleared Dec 09, 1982
PRISMA C-REACTIVE PROTEIN ASSAY
K823416
Syva Co.
Immunology · 24d
Cleared Dec 09, 1982
PRISMA-C-REACTIVE PROTEIN CALIBRATORS
K823417
Syva Co.
Chemistry · 24d
Cleared Jul 27, 1982
EMIT C-REACTIVE PROTEIN AUTOCAROUSEL
K822067
Syva Co.
Chemistry · 13d
Cleared Jul 22, 1982
C-REACTIVE PROTEIN CONTROL
K821412
Syva Co.
Chemistry · 71d
Cleared Jul 22, 1982
QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.
K821984
Kallestad Laboratories, Inc.
Immunology · 16d
Cleared Jun 25, 1981
QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.
K811617
Kallestad Laboratories, Inc.
Immunology · 17d
Cleared Dec 31, 1979
AGGLUTINOTEST-C-REACTIVE PROTEIN
K791461
Volu Sol Medical Industries
Immunology · 147d
Cleared Sep 17, 1979
HUMAN, C-REACTIVE PROTEIN (CRP)
K791650
Beckman Instruments, Inc.
Immunology · 27d
Cleared Aug 11, 1976
TEST, SLIDE FOR C-REATIVE PROTEIN
K760354
Icl Scientific
Immunology · 9d
Cleared Aug 03, 1976
TEST, C-REATIVE PROTEIN, LATEX SLIDE
K760035
Gamma Biologicals, Inc.
Immunology · 50d