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

FDA 510(k) Number Applicant Device Name Decision Date
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
K961256 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT 05/15/1996
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
K042476 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS 12/01/2004
K011649 RANDOX LABORATORIES, LTD. RANDOX VALPROIC ACID 01/15/2002
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
K972132 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS 07/30/1997
K011947 SYVA CO. EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL 07/02/2001


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