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

    LEUCINE AMINOPEPTIDASE REAGENT

    K Number: K844965 · Decision Mar 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    LEUCINE AMINOPEPTIDASE REAGENT
    K Number
    K844965
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1460
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Alladin Diagnostic, Inc.
    Date Received
    December 24, 1984
    Decision Date
    March 5, 1985
    Product Code
    JGG
    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
    JGG L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JGG), ordered by most recent decision date.

    SYNCHRON CX SYSTEMS (LAP) REAGENT KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Alladin Diagnostic, Inc.

    K Number Device Name
    K823900 GLUCOSE-6-PHOSPHATE DEHYDROGENASE