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

    AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS

    K Number: K923133 · Decision Sep 25, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    88

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS
    K Number
    K923133
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microprobe Corp.
    Date Received
    June 29, 1992
    Decision Date
    September 25, 1992
    Product Code
    MJM
    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
    MJM Dna Probe, Gardnerella Vaginalis

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MJM), ordered by most recent decision date.

    INDICARD TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Microprobe Corp.

    K Number Device Name
    K931151 AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA
    K931374 AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
    K922457 AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA
    K920536 AFFIRM VP SAMPLE COLLECTION SET
    K923268 AFFIRM PROCESSOR