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

    SANDARE FAST 340 PHOSPHORUS PROCEDURE

    K Number: K812670 · Decision Oct 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    23
    Review Days
    11

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    Basic Information

    Device Name
    SANDARE FAST 340 PHOSPHORUS PROCEDURE
    K Number
    K812670
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1520
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sandare Chemical Co., Inc.
    Date Received
    September 21, 1981
    Decision Date
    October 2, 1981
    Product Code
    CED
    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
    CED 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

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