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

    BLOOD KIT, SEXUAL ASSAULT KIT

    K Number: K945245 · Decision Feb 1, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    1
    Review Days
    97

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    Basic Information

    Device Name
    BLOOD KIT, SEXUAL ASSAULT KIT
    K Number
    K945245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lynn Peavey Co.
    Date Received
    October 27, 1994
    Decision Date
    February 1, 1995
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    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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