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

    URINE COLLECTION KIT/DEVICE

    K Number: K913330 · Decision Aug 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    32

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    Basic Information

    Device Name
    URINE COLLECTION KIT/DEVICE
    K Number
    K913330
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1450
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Implements, Inc.
    Date Received
    July 25, 1991
    Decision Date
    August 26, 1991
    Product Code
    KHP
    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
    KHP Acid, Lactic, Enzymatic Method

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    Other Clearances by Medical Implements, Inc.

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