BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO

    K Number: K792196 · Decision Nov 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    12

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    Basic Information

    Device Name
    8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO
    K Number
    K792196
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Photovolt Corp.
    Date Received
    November 1, 1979
    Decision Date
    November 13, 1979
    Product Code
    JJR
    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
    JJR Electrolyte Controls (Assayed And Unassayed)

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    Other Clearances by Photovolt Corp.

    K Number Device Name
    K800453 PHOTOVOLT PVA 4M+2 ANALYZER