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
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
K955857 BEHRING DIAGNOSTICS, INC. N PROTEIN STANDARS SY 02/21/1996
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
K032796 IBL GMBH IBL C3D-CIC EIA TEST 01/13/2004
K962199 INSTRUMENTATION LABORATORY CO. QUANTEX C3 09/25/1996
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
K000469 RANDOX LABORATORIES, LTD. RANDOX COMPLEMENT C3 03/27/2000
K012361 ROCHE DIAGNOSTICS CORP. TINA-QUANT COMPLEMENT C3C TEST SYSTEM 11/29/2001
K100179 THE BINDING SITE GROUP, LTD. SPAPLUS 08/13/2010
K981783 THE BINDING SITE, LTD. C3 MININEPH ANTISERUM 12/20/1999
K063150 THERMO ELECTRON OY COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL 03/19/2007
K010326 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT C3 06/25/2001


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