BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS

    K Number: K915814 · Decision Mar 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS
    K Number
    K915814
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Sirchie Finger Print Laboratories, Inc.
    Date Received
    December 30, 1991
    Decision Date
    March 27, 1992
    Product Code
    JKA
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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