BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇪 Ireland

    GASTRIN EIA MODEL 06B-555017

    K Number: K961276 · Decision May 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    GASTRIN EIA MODEL 06B-555017
    K Number
    K961276
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1325
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosyn , Ltd.
    Date Received
    April 3, 1996
    Decision Date
    May 30, 1996
    Product Code
    CGC
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CGC Radioimmunoassay, Gastrin

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