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

    SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY

    K Number: K941497 · Decision May 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    126
    Applicant Total
    6
    Review Days
    57

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    Basic Information

    Device Name
    SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY
    K Number
    K941497
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1030
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Solarcare, Inc.
    Date Received
    March 28, 1994
    Decision Date
    May 24, 1994
    Product Code
    CKA
    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
    CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt

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    Other Clearances by Solarcare, Inc.

    K Number Device Name
    K934775 STC COCAINE METABOLITE EIA
    K944372 STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA
    K941496 SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY
    K934376 STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA
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