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

    ECLIPSE ICA TSH

    K Number: K910256 · Decision Feb 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    7
    Review Days
    31

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    Basic Information

    Device Name
    ECLIPSE ICA TSH
    K Number
    K910256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biotope, Inc.
    Date Received
    January 22, 1991
    Decision Date
    February 22, 1991
    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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    Other Clearances by Biotope, Inc.

    K Number Device Name
    K905145 ECLIPSE ICA CHOLESTEROL
    K910302 ECLIPSE ICA ANALYZER
    K905601 ECLIPSE ICA TRIGLYCERIDES
    K905719 ECLIPSE ICA DIGOXIN
    K905602 ECLIPSE ICA BUN
    K905144 ECLIPSE ICA GLUCOSE