FDA 510(k) Applications for Medical Device Product Code "LEG"
(Enzyme Immunoassay, Valproic Acid)

FDA 510(k) Number Applicant Device Name Decision Date
K941615 ABBOTT LABORATORIES AXSYM VALPROIC ACID 08/16/1994
K803236 ABBOTT LABORATORIES CYBREX VALPROIC ACID 01/28/1981
K090358 ABBOTT LABORATORIES INC ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 08/06/2009
K964442 BAYER CORP. VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM 12/18/1996
K042807 BAYER HEALTHCARE, LLC ADVIA IMS VALPROIC ACID METHOD 02/08/2005
K031870 BECKMAN COULTER, INC. SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT 07/15/2003
K922844 BECKMAN INSTRUMENTS, INC. BECKMAN VALPROIC ACID REAGENT 10/26/1992
K961256 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT 05/15/1996
K934061 BIOTRACK, INC. BIOTRACK VALPROIC ACID TEST CARTRIDGE 12/29/1993
K982880 DADE BEHRING, INC. DIMENSION(R) VALPROIC (VALP) ACID METHOD 08/25/1998
K002551 DADE BEHRING, INC. EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL 10/11/2000
K000005 DIAGNOSTIC PRODUCTS CORP. IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 03/03/2000
K961988 DIAGNOSTIC REAGENTS, INC. VALPROIC ACID EIA TEST 07/16/1996
K911688 INTL. BIOCLINICAL, INC. INNOFLUOR(TM) VALPROIC ACID REAGENT SET 07/05/1991
K930734 MICROGENICS CORP. CEDIA VALPORIC ACID ASSAY 09/21/1993
K830789 MILES LABORATORIES, INC. AMES TDA VALPROIC ACID TEST 04/12/1983
K042476 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS 12/01/2004
K901538 PB DIAGNOSTIC SYSTEMS, INC. MODIFIED OPUS VALPROIC ACID TEST SYSTEM 06/26/1990
K011649 RANDOX LABORATORIES, LTD. RANDOX VALPROIC ACID 01/15/2002
K953224 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID 10/30/1995
K891581 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS 08/15/1989
K925003 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS 12/03/1992
K060690 ROCHE DIAGNOSTICS CORP. ONLINE VALPROIC ACID 08/08/2006
K032049 ROCHE DIAGNOSTICS CORP. ROCHE ONLINE TDM VALPROIC ACID 08/22/2003
K973581 SCHIAPPARELLI BIOSYSTEMS, INC. ACE VALPROIC ACID REAGENT, AED CALIBRATORS 11/12/1997
K030405 SERADYN QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 04/28/2003
K936208 SERADYN, INC. VALPROIC ACID 03/11/1994
K972132 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS 07/30/1997
K943866 SIGMA DIAGNOSTICS, INC. VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS 11/10/1994
K011947 SYVA CO. EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL 07/02/2001
K832719 SYVA CO. EMIT AED VALPROIC ACID ASSAY 10/04/1983
K801207 SYVA CO. EMIT VALPROIC ACID ASSAY 06/20/1980
K862652 SYVA CO. EMIT VALPROIC ACID ASSAY 07/29/1986
K822933 SYVA CO. SYVA ADVANCE EMIT AED VALPROIC ACID ASSA 10/27/1982
K895569 TUDOR LABORATORIES, INC. VALPROIC ACID (FPIA) KIT 10/03/1989


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