FDA 510(k) Applications for Medical Device Product Code "CZW"
(Complement C3, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K983441 ABBOTT LABORATORIES C3 11/04/1998
K781653 ANTIBODIES INC. NEPHELRATE ANTISERUMS C3C 11/08/1978
K850588 APPLICATIONS LAB SPQ TEST SYSTEM FOR COMPLEMENT C3 03/05/1985
K991907 BAYER CORP. ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM 11/09/1999
K032035 BECKMAN COULTER, INC. SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI 08/07/2003
K964842 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT 06/11/1997
K952594 BEHRING DIAGNOSTICS, INC. N PROTEIN STANDARD SY 07/17/1995
K955857 BEHRING DIAGNOSTICS, INC. N PROTEIN STANDARS SY 02/21/1996
K871024 BOEHRINGER MANNHEIM CORP. PRECIMAT(R) C3 05/15/1987
K800212 CALBIOCHEM-BEHRING CORP. COMPLEMENT C3 REAGENT SYSTEM 02/19/1980
K851286 COOPER BIOMEDICAL, INC. RADIAL IMMUNODIFFUSION PLATES C3 & C4 06/05/1985
K964298 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA MULTI V-NL 07/14/1997
K994296 DADE BEHRING, INC. DIMENSION C3 FLEX REAGENT CARTRIDGE 03/01/2000
K061852 DADE BEHRING, INC. DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH 09/22/2006
K050665 DADE BEHRING, INC. N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) 05/02/2005
K871346 DAKO CORP. DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY 04/21/1987
K812491 DAKO CORP. IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3 09/23/1981
K831905 DAKO CORP. RABBITT ANTISERUM TO HUMAN C3C 07/18/1983
K892125 DIAMEDIX CORP. EZ COMPLEMENT C2 04/14/1989
K892127 DIAMEDIX CORP. EZ COMPLEMENT C3 04/14/1989
K853466 GILFORD GILFORD C3 COMPLEMENT REAGENT 09/16/1985
K032796 IBL GMBH IBL C3D-CIC EIA TEST 01/13/2004
K861362 IMMUNOMEDICS, INC. IMMUNOMEDICS SERUM ELISA TEST SYSTEM 06/06/1986
K920007 INSTRUMENTATION LABORATORY CO. IL TEST COMPLEMENT 3 06/16/1992
K962199 INSTRUMENTATION LABORATORY CO. QUANTEX C3 09/25/1996
K830668 INTL. DIAGNOSTIC TECHNOLOGY FIAX COMPLEMENT C3 TEST KIT 04/05/1983
K801363 J.T. BAKER CHEMICAL CO. COMPLEMENT C3 NEPHELOMETRIC ASSAY 06/30/1980
K871939 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 C3 ANTIBODY PACK 06/12/1987
K993437 KAMIYA BIOMEDICAL CO. K-ASSAY C3 11/24/1999
K962409 OLYMPUS AMERICA, INC. OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT 10/18/1996
K042494 ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III 10/19/2004
K760148 OXFORD LABORATORIES, INC. SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN 07/20/1976
K000469 RANDOX LABORATORIES, LTD. RANDOX COMPLEMENT C3 03/27/2000
K911900 REAGENTS APPLICATIONS, INC. RAICHEM SPIA C3 REAGENT 05/09/1991
K012361 ROCHE DIAGNOSTICS CORP. TINA-QUANT COMPLEMENT C3C TEST SYSTEM 11/29/2001
K810501 SCRIPPS-MILES, INC. SCRIPPSYSTEM C3 RID KIT 04/08/1981
K791404 SHERWOOD MEDICAL CO. LANCER L-INA ANTI-C3 10/17/1979
K834604 TECHNICON INSTRUMENTS CORP. C3 ANTISERUM CONTROL 01/24/1984
K100179 THE BINDING SITE GROUP, LTD. SPAPLUS 08/13/2010
K981783 THE BINDING SITE, LTD. C3 MININEPH ANTISERUM 12/20/1999
K902382 THE BINDING SITE, LTD. C3C AND C4 RID KITS 09/07/1990
K063150 THERMO ELECTRON OY COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL 03/19/2007
K890675 UNIPATH LTD. THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4 03/06/1989
K010326 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT C3 06/25/2001


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