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
73–96 of 126
Cleared Jul 22, 1991
HUMAN C-REACTIVE PROTEIN RID KIT
K905633
The Binding Site, Ltd.
Immunology · 220d
Cleared Sep 27, 1989
WAKO(TM) AUTOKIT CRP
K895598
Wako Chemicals USA, Inc.
Chemistry · 9d
Cleared May 09, 1989
TECHNICON DPA-1 (TM) CRP METHOD
K892198
Technicon Instruments Corp.
Immunology · 36d
Cleared May 09, 1989
SPQ TM TEST SYSTEM II FOR CRP
K892526
Atlantic Antibodies
Immunology · 28d
Cleared Feb 17, 1989
V-TREND TARGET CRP TEST
K890423
Texas Immunology, Inc.
Immunology · 22d
Cleared Oct 19, 1988
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
K884101
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 63d
Cleared Mar 30, 1988
KALLESTAD QM300 CALIBRATOR C PACK
K880729
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 36d
Cleared Mar 25, 1988
KALLESTAD QM2/QM300 CONTROL C PACK
K880730
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 31d
Cleared Mar 21, 1988
VISION(R) CRP
K875345
Abbott Laboratories
Immunology · 82d
Cleared Feb 25, 1988
MODIFIED CRP LATEX TEST
K880016
Sclavo, Inc.
Immunology · 51d
Cleared Oct 13, 1987
CRP
K873865
Unipath , Ltd.
Immunology · 50d
Cleared Jun 15, 1987
TINA-QUANT [A] CRP
K871895
Boehringer Mannheim Corp.
Immunology · 31d
Cleared May 06, 1987
PRECIMAT(R) CRP
K871055
Boehringer Mannheim Corp.
Immunology · 50d
Cleared Mar 16, 1987
VISION(TM) CRP
K864131
Abbott Laboratories
Immunology · 146d
Cleared Oct 15, 1986
C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS
K863628
Technicon Instruments Corp.
Immunology · 28d
Cleared Sep 26, 1986
ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST
K863328
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 30d
Cleared Sep 26, 1986
ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR
K863329
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 30d
Cleared Jun 10, 1986
DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR
K860549
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 117d
Cleared Jun 10, 1986
DU PONT C-REACTIVE PROTEIN (CRP) ASSAY
K860550
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 117d
Cleared Jan 24, 1986
TDX C-REACTIVE PROTEIN
K854542
Abbott Laboratories
Immunology · 72d
Cleared Jun 05, 1985
SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
K851842
Atlantic Antibodies
Immunology · 40d
Cleared Aug 26, 1983
FIAX CRP TEST KIT
K832054
Intl. Diagnostic Technology
Immunology · 60d
Cleared Jul 19, 1983
RADIAL IMMUNO-TEST FOR HUMAN C-REACTI
K831958
Kent Laboratories, Inc.
Chemistry · 32d
Cleared Dec 09, 1982
PRISMA C-REACTIVE PROTEIN CONTROLS
K823415
Syva Co.
Chemistry · 24d