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

    AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA

    K Number: K931151 · Decision Jun 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    102

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    Basic Information

    Device Name
    AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA
    K Number
    K931151
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microprobe Corp.
    Date Received
    March 8, 1993
    Decision Date
    June 18, 1993
    Product Code
    MLA
    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
    MLA Dna Probe, Yeast

    Similar 510(k) Clearances

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

    AFFIRM VPIII MICROBIAL IDENTIFICATION TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology
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    Other Clearances by Microprobe Corp.

    K Number Device Name
    K931374 AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
    K923133 AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS
    K922457 AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA
    K920536 AFFIRM VP SAMPLE COLLECTION SET
    K923268 AFFIRM PROCESSOR