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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