BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)

    K Number: K915003 · Decision Nov 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    448
    Review Days
    22

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    Basic Information

    Device Name
    EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
    K Number
    K915003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Syva Co.
    Date Received
    November 7, 1991
    Decision Date
    November 29, 1991
    Product Code
    DKB
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DKB Calibrators, Drug Mixture

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    Other Clearances by Syva Co.

    K Number Device Name
    K011878 EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
    K012257 EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
    K011947 EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
    K011528 EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
    K011347 EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
    K993981 SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
    K993980 SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
    K993987 SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
    K993982 SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
    K993988 SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
    Search all 448 clearances from Syva Co. →