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
25–48 of 70
Cleared Jun 13, 2002
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
K020603
Good Biotech Corp.
Chemistry · 108d
Cleared Jan 08, 2002
WAMPOLE HS-CRP ELISA
K011855
Carter-Wallace, Inc.
Chemistry · 209d
Cleared Dec 06, 2001
BAYER ADVIA IMS SYSTEM
K012337
Bayer Corp.
Chemistry · 135d
Cleared Dec 04, 2001
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
K011958
Denka Seiken'S
Chemistry · 165d
Cleared May 10, 2001
CRP HS TEST SYSTEM
K003400
Roche Diagnostics Corp.
Immunology · 190d
Cleared Feb 14, 2001
RCRP FLEX REAGENT CARTRIDGE
K003419
Dade Behring, Inc.
Immunology · 104d
Cleared Jan 22, 2001
WAKO CRP-UL, CRP-UL CALIBRATOR SET
K003342
Wako Chemicals USA, Inc.
Chemistry · 89d
Cleared Dec 26, 2000
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
K003372
Diagnostic Products Corp.
Immunology · 57d
Cleared Oct 25, 2000
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
K002918
Olympus America, Inc.
Immunology · 36d
Cleared Jun 01, 1999
CRP
K991372
Abbott Laboratories
Immunology · 42d
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 Dec 13, 1995
CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM
K955042
Shared Systems, Inc.
Immunology · 40d
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 Mar 19, 1991
RHEUMAJET CRP
K910686
Biokit USA, Inc.
Immunology · 28d
Cleared Nov 01, 1990
CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST
K904497
Biotrax, Inc.
Immunology · 30d
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 Nov 08, 1989
QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
K896272
Biokit USA, Inc.
Immunology · 9d
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