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510(k) K002551

Device
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL
Applicant
DADE BEHRING, INC.
510(k) number
K002551
Product code
LEG  
Decision
Substantially Equivalent (SESE)
Decision date
2000-10-11
Date received
2000-08-17
Regulation
862.3645
Classification name
Enzyme Immunoassay, Valproic Acid
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAUL L ROGERS
Address
3403 Yerba Buena Rd. San Jose CA US 95161 95161

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
K042807ADVIA IMS VALPROIC ACID METHODBayer Healthcare, LLC2005-02-08
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
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

Legacy Summary#

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FDA Review#

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