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

    TRYPSIN 1%

    K Number: K771955 · Decision Nov 22, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    1
    Applicant Total
    57
    Review Days
    36

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    Basic Information

    Device Name
    TRYPSIN 1%
    K Number
    K771955
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.4400
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Flow Laboratories, Inc.
    Date Received
    October 17, 1977
    Decision Date
    November 22, 1977
    Product Code
    IBG
    Advisory Committee
    Pathology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IBG Trypsin

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