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510(k) K934061

Device
BIOTRACK VALPROIC ACID TEST CARTRIDGE
Applicant
BIOTRACK, INC.
510(k) number
K934061
Product code
LEG  
Decision
Substantially Equivalent (SESE)
Decision date
1993-12-29
Date received
1993-08-19
Regulation
862.3645
Classification name
Enzyme Immunoassay, Valproic Acid
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BERNELLE SAPERSTEIN
Address
1058 Huff Ave. Mountain View CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
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

Legacy Summary#

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FDA Review#

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