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

    TSH (MICROWELL) ELISA

    K Number: K962216 · Decision Sep 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    10
    Review Days
    101

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    Basic Information

    Device Name
    TSH (MICROWELL) ELISA
    K Number
    K962216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biomerica, Inc.
    Date Received
    June 10, 1996
    Decision Date
    September 19, 1996
    Product Code
    JLW
    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
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

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