FDA 510(k) Applications for Medical Device Product Code "DBI"
(Complement C4, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K983356 ABBOTT LABORATORIES C4 11/04/1998
K850585 APPLICATIONS LAB SPQ TEST SYSTEM FOR COMPLEMENT C4 03/01/1985
K890564 ATLANTIC ANTIBODIES SPQ(TM) ANTIBODY REAGENT SET II FOR C4 02/17/1989
K871023 BOEHRINGER MANNHEIM CORP. PRECIMAT(R) C4 05/14/1987
K870931 BOEHRINGER MANNHEIM CORP. TINA-QUANT(R) (A) C4 03/24/1987
K964297 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA C4 TEST KIT 07/14/1997
K964300 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA MULTI V-NL 07/14/1997
K994293 DADE BEHRING, INC. DIMENSION C4 FLEX REAGENT CARTRIDGE 03/01/2000
K812490 DAKO CORP. IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4 09/23/1981
K831906 DAKO CORP. RABBIT ANTISERUM TO HUMAN C4 07/19/1983
K892129 DIAMEDIX CORP. EZ COMPLEMENT C4 04/14/1989
K772004 G.D. SEARLE AND CO. HUMAN C4 COMPLEMENT CONTROL SERUM 11/03/1977
K772002 G.D. SEARLE AND CO. PLATES FOR HUMAN C4 COMPLEMENT 11/02/1977
K772073 GELMAN INSTRUMENT CO. RADIAL IMMUNODIFFUSION KIT-COMP. 3 02/03/1978
K853468 GILFORD GILFORD C4 COMPLEMENT REAGENT 09/16/1985
K920010 INSTRUMENTATION LABORATORY CO. IL TEST COMPLEMENT 4 03/13/1992
K962198 INSTRUMENTATION LABORATORY CO. QUANTEX C4 09/26/1996
K830669 INTL. DIAGNOSTIC TECHNOLOGY FIAX COMPLEMENT C4 TEST KIT 04/08/1983
K801361 J.T. BAKER CHEMICAL CO. COMPLEMENT C4 NEPHELOMETRIC ASSAY 06/30/1980
K872599 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 C4 ANTIBODY PACK 07/23/1987
K772247 KALLESTAD LABORATORIES, INC. COMPLEMENT C4 NEPHELOMETRIC ASSAY 12/22/1977
K855012 KALLESTAD LABORATORIES, INC. QUANTIMETRIC PLUS C4 REAGENT KIT 02/26/1986
K993481 KAMIYA BIOMEDICAL CO. K-ASSAY C4 11/29/1999
K962582 OLYMPUS AMERICA, INC. OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT 10/18/1996
K802196 PROTOS LABORATORIES GOAT ANTI-HUMAN COMPLEMENT C4 10/31/1980
K000468 RANDOX LABORATORIES, LTD. RANDOX COMPLEMENT C4 03/27/2000
K911899 REAGENTS APPLICATIONS, INC. RAICHEM SPIA C4 REAGENT 05/09/1991
K012359 ROCHE DIAGNOSTICS CORP. TINA-QUANT COMPLEMENT C4 TEST SYSTEM 11/29/2001
K810502 SCRIPPS-MILES, INC. SCRIPPSYSTEM C4 RID KIT 04/08/1981
K834605 TECHNICON INSTRUMENTS CORP. C4 ANTIGEN ANTIBODY CONTROL 01/24/1984
K882621 TECHNICON INSTRUMENTS CORP. COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM 07/08/1988
K100455 THE BINDING SITE SPAPLUS ANALYZER 09/03/2010
K981785 THE BINDING SITE, LTD. C4 MININEPH ANTISERUM 12/20/1999
K010325 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT C4 06/25/2001


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact