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

    REVISED LABELING FOR SYVA METHAQUALONE ASSAYS

    K Number: K874199 · Decision Oct 28, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    448
    Review Days
    14

    Basic Information

    Device Name
    REVISED LABELING FOR SYVA METHAQUALONE ASSAYS
    K Number
    K874199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3630
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    SYVA CO.
    Date Received
    October 14, 1987
    Decision Date
    October 28, 1987
    Product Code
    KXS
    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
    KXS Radioimmunoassay, Methaqualone

    Similar 510(k) Clearances

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

    MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SYNCHRON SYSTEMS METHAQUALONE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ROCHE ABUSCREEN ONLINE FOR METHAQUALONE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    METHAQUALONE ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SYVA EMIT II METHAQUALONE ASSAY

    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
    K011947 EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
    K011528 EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
    K011347 EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
    K993980 SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
    K993981 SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
    K993029 ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89
    K993031 ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54
    K993988 SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
    Search all 448 clearances from SYVA CO. →