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510(k) K915755

Device
BIOTRACK PHENYTOIN TEST CARTRIDGE
Applicant
BIOTRACK, INC.
510(k) number
K915755
Product code
DIP  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-23
Date received
1991-12-23
Regulation
862.3350
Classification name
Enzyme Immunoassay, Diphenylhydantoin
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JILL FINDLAY
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 DIP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K080696ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01Abbott Laboratories2008-09-11
K063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSThermo Electron OY2007-10-17
K030428ROCHE ONLINE TDM PHENYTOINRoche Diagnostics Corp.2003-04-28
K011393RANDOX PHENYTOINRandox Laboratories, Ltd.2001-12-04
K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229Syva Co.2001-05-17
K000006IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6Diagnostic Products Corp.2000-02-28
K993026ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORSSyva Co.2000-01-27
K973414ACE PHENYTOIN REAGENT, AED CALIBRATORSSchiapparelli Biosystems, Inc.1997-11-04
K963840CEDIA PHENYTOIN II ASSAYBoehringer Mannheim Corp.1996-11-20
K943980IL TEST PHENYTION CALIBRATORSInstrumentation Laboratory CO1995-05-01
K945725PHENYTION EIA TESTDiagnostic Reagents, Inc.1995-02-03
K944085ACE(TM) CEDIA(R) PHENYTOIN ASSAYSchiapparelli Biosystems, Inc.1994-12-28
K941142KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOINEastman Kodak Company1994-06-13
K932686PARAMAX(R) PHENYTOIN REAGENTBaxter Diagnostics, Inc.1993-11-26
K913429EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORSSyva Co.1991-08-26

Legacy Summary#

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FDA Review#

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