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DLZ — Enzyme Immunoassay, Phenobarbital Class II

FDA Device Classification

Classification Details

Product Code
DLZ
Device Class
Class II
Regulation Number
862.3660
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K210858ortho-clinical diagnosticsVITROS Chemistry Products PHBR SlidesAugust 13, 2021
K123271microgenicsABBOTT PHENOBARBITAL ASSAYApril 26, 2013
K081231abbott laboratoriesARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODESeptember 26, 2008
K071644roche diagnosticsONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620September 12, 2007
K011303randox laboratoriesRANDOX PHENOBARBITALJuly 2, 2001
K011528syvaEMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229June 6, 2001
K000012diagnostic productsIMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5March 3, 2000
K993031syvaABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54January 27, 2000
K984288ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS PHBR SLIDESJanuary 26, 1999
K946210diagnostic reagentsPHENOBARBITAL ENZYME IMMUNOASSAYFebruary 10, 1995
K943981instrumentation laboratoryIL TEST PHENOBARBITAL CALIBRATORSJanuary 18, 1995
K944932dupont medical productsPHENOBARBITAL FLEX REAGENT CARTRIDGEDecember 28, 1994
K942501schiapparelli biosystemsACE CEDIA PHENOBARBITAL ASSAYOctober 6, 1994
K935568baxter diagnosticsPARAMAX PHENOBARBITAL REAGENT AND CALIBRATORSMarch 11, 1994
K913190syvaEMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORSAugust 26, 1991
K910355instrumentation laboratoryIL PHENOBARBITAL ASSAY SYSTEMApril 3, 1991
K896861pb diagnostic systemsOPUS PHENOBARBITAL TEST SYSTEMJanuary 11, 1990
K884419technicon instrumentsTECHNICON RA-PHENOBARBITALNovember 22, 1988
K874625syvaEMIT CONVENIENCE PACK: PHENOBARBITAL ASSAYDecember 22, 1987
K864926em diagnostic systemsEMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95January 7, 1987