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

    SENTINEL LIPASE LIQUID MODEL 17.401B

    K Number: K961179 · Decision Jul 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    115

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    Basic Information

    Device Name
    SENTINEL LIPASE LIQUID MODEL 17.401B
    K Number
    K961179
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1465
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Equal Diagnostics, Inc.
    Date Received
    March 26, 1996
    Decision Date
    July 19, 1996
    Product Code
    CHI
    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
    CHI Lipase-Esterase, Enzymatic, Photometric, Lipase

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    Other Clearances by Equal Diagnostics, Inc.

    K Number Device Name
    K981800 SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606