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

    SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY

    K Number: K941496 · Decision Oct 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    115
    Applicant Total
    6
    Review Days
    213

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    Basic Information

    Device Name
    SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY
    K Number
    K941496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Solarcare, Inc.
    Date Received
    March 28, 1994
    Decision Date
    October 27, 1994
    Product Code
    CEK
    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
    CEK Biuret (Colorimetric), Total Protein

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