FDA.reportPublic FDA data

510(k) K042807

Device
ADVIA IMS VALPROIC ACID METHOD
Applicant
Bayer Healthcare, LLC
510(k) number
K042807
Product code
LEG
Decision
Substantially Equivalent (SESE)
Decision date
2005-02-08
Date received
2004-10-12
Regulation
862.3645
Classification name
Enzyme Immunoassay, Valproic Acid
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
ANDRES HOLLE
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LEG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K090358ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35Abbott Laboratories, Inc.2009-08-06
K060690ONLINE VALPROIC ACIDRoche Diagnostics Corp.2006-08-08
K042476VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOSOrtho-Clinical Diagnostics, Inc.2004-12-01
K032049ROCHE ONLINE TDM VALPROIC ACIDRoche Diagnostics Corp.2003-08-22
K031870SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENTBeckman Coulter, Inc.2003-07-15
K030405QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075Seradyn2003-04-28
K011649RANDOX VALPROIC ACIDRandox Laboratories, Ltd.2002-01-15
K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULSyva Co.2001-07-02
K002551EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109ULDade Behring, Inc.2000-10-11
K000005IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6Diagnostic Products Corp.2000-03-03
K982880DIMENSION(R) VALPROIC (VALP) ACID METHODDade Behring, Inc.1998-08-25
K973581ACE VALPROIC ACID REAGENT, AED CALIBRATORSSchiapparelli Biosystems, Inc.1997-11-12
K972132SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORSSigma Diagnostics, Inc.1997-07-30
K964442VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEMBayer Corp.1996-12-18
K961988VALPROIC ACID EIA TESTDiagnostic Reagents, Inc.1996-07-16