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

    AFFIRM VP SAMPLE COLLECTION SET

    K Number: K920536 · Decision Jul 30, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    176

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    Basic Information

    Device Name
    AFFIRM VP SAMPLE COLLECTION SET
    K Number
    K920536
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microprobe Corp.
    Date Received
    February 5, 1992
    Decision Date
    July 30, 1992
    Product Code
    LIO
    Advisory Committee
    Microbiology
    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
    LIO Device, Specimen Collection

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    Other Clearances by Microprobe Corp.

    K Number Device Name
    K931151 AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA
    K931374 AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
    K923133 AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS
    K922457 AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA
    K923268 AFFIRM PROCESSOR