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

    LIPASE REAGENT SET

    K Number: K915706 · Decision Feb 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    13
    Review Days
    81

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    Basic Information

    Device Name
    LIPASE REAGENT SET
    K Number
    K915706
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1465
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tech Intl. Co.
    Date Received
    November 29, 1991
    Decision Date
    February 18, 1992
    Product Code
    CET
    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
    CET Olive Oil Emulsion (Turbidimetric), Lipase

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    Other Clearances by Tech Intl. Co.

    K Number Device Name
    K915704 AMYLASE (KINETIC) REAGENT SET
    K915705 ACID PHOSPHATASE REAGENT SET
    K915707 AMMONIA REAGENT SET
    K914158 URIC ACID REAGENT SET
    K915710 AMYLASE (COLORIMETRIC) REAGENT SET
    K914160 CHOLESTEROL REGEANT SET
    K915709 CREATINE KINASE-MB (CK-MB) REAGENT SET
    K914159 GLUCOSE REAGENT SET
    K915708 INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET
    K914171 IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE
    Search all 13 clearances from Tech Intl. Co. →