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

    AUTOMATED ENZYME

    K Number: K780962 · Decision Jul 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    4
    Applicant Total
    44
    Review Days
    45

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    Basic Information

    Device Name
    AUTOMATED ENZYME
    K Number
    K780962
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    June 12, 1978
    Decision Date
    July 27, 1978
    Product Code
    KSK
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KSK Solution, Stabilized Enzyme

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    K810077 OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
    K802610 ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
    K791113 LOW IONIC STRENGTH SOLUTION (LISS)
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    K781225 GLOBULIN TEST, HUMAN THYROXINE BINDING
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