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

    SMAC SYS., SUPPLEMENTAL PRODUCTS FOR

    K Number: K771033 · Decision Aug 4, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    126
    Applicant Total
    5
    Review Days
    56

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    Basic Information

    Device Name
    SMAC SYS., SUPPLEMENTAL PRODUCTS FOR
    K Number
    K771033
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1030
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Mid Tech, Inc.
    Date Received
    June 9, 1977
    Decision Date
    August 4, 1977
    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 Mid Tech, Inc.

    K Number Device Name
    K810951 REAGENTS FOR QUANT. ENZYMATIC DETER.-TR.
    K791869 GLUCOSE OXIDASE (FRINDER) KIT
    K791313 ARS, CHEMISTRY
    K770508 SMAC SYSTEM