DBI · Class II · 21 CFR 866.5240

FDA Product Code DBI: Complement C4, Antigen, Antiserum, Control

Leading manufacturers include Instrumentation Laboratory CO, Crestat Diagnostics, Inc. and G.D. Searle and Co..

34
Total
34
Cleared
82d
Avg days
1977
Since

FDA 510(k) Cleared Complement C4, Antigen, Antiserum, Control Devices (Product Code DBI)

34 devices
1–24 of 34
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
K012359
Roche Diagnostics Corp.
Immunology · 127d
Cleared Jun 25, 2001
WAKO AUTOKIT C4
K010325
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Mar 27, 2000
RANDOX COMPLEMENT C4
K000468
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Mar 01, 2000
DIMENSION C4 FLEX REAGENT CARTRIDGE
K994293
Dade Behring, Inc.
Immunology · 71d
Cleared Dec 20, 1999
C4 MININEPH ANTISERUM
K981785
The Binding Site, Ltd.
Immunology · 579d
Cleared Nov 29, 1999
K-ASSAY C4
K993481
Kamiya Biomedical Co.
Immunology · 46d
Cleared Nov 04, 1998
C4
K983356
Abbott Laboratories
Immunology · 41d
Cleared Jul 14, 1997
N-ASSAY TIA C4 TEST KIT
K964297
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964300
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Oct 18, 1996
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
K962582
Olympus America, Inc.
Immunology · 109d
Cleared Sep 26, 1996
QUANTEX C4
K962198
Instrumentation Laboratory CO
Immunology · 111d
Cleared Mar 13, 1992
IL TEST COMPLEMENT 4
K920010
Instrumentation Laboratory CO
Immunology · 71d
Cleared May 09, 1991
RAICHEM SPIA C4 REAGENT
K911899
Reagents Applications, Inc.
Immunology · 13d
Cleared Apr 14, 1989
EZ COMPLEMENT C4
K892129
Diamedix Corp.
Immunology · 18d
Cleared Feb 17, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR C4
K890564
Atlantic Antibodies
Immunology · 24d
Cleared Jul 08, 1988
COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM
K882621
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 23, 1987
QM300 C4 ANTIBODY PACK
K872599
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 21d
Cleared May 14, 1987
PRECIMAT(R) C4
K871023
Boehringer Mannheim Corp.
Immunology · 59d
Cleared Mar 24, 1987
TINA-QUANT(R) (A) C4
K870931
Boehringer Mannheim Corp.
Immunology · 15d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS C4 REAGENT KIT
K855012
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Jan 24, 1984
C4 ANTIGEN ANTIBODY CONTROL
K834605
Technicon Instruments Corp.
Immunology · 116d
Cleared Jul 19, 1983
RABBIT ANTISERUM TO HUMAN C4
K831906
Dako Corp.
Immunology · 35d
Cleared Apr 08, 1983
FIAX COMPLEMENT C4 TEST KIT
K830669
Intl. Diagnostic Technology
Immunology · 35d
Cleared Sep 23, 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4
K812490
Dako Corp.
Immunology · 23d

About Product Code DBI - Regulatory Context