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

    EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL

    K Number: K011947 · Decision Jul 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    34
    Applicant Total
    448
    Review Days
    11

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
    K Number
    K011947
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syva Co.
    Date Received
    June 21, 2001
    Decision Date
    July 2, 2001
    Product Code
    LEG
    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
    LEG Enzyme Immunoassay, Valproic Acid

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LEG), ordered by most recent decision date.

    ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ONLINE VALPROIC ACID

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ADVIA IMS VALPROIC ACID METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ROCHE ONLINE TDM VALPROIC ACID

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    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
    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
    K993026 ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
    Search all 448 clearances from Syva Co. →