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

    CRAG LATERAL FLOW ASSAY (LFA)

    K Number: K112422 · Decision Mar 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    9
    Applicant Total
    26
    Review Days
    218

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    Basic Information

    Device Name
    CRAG LATERAL FLOW ASSAY (LFA)
    K Number
    K112422
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3165
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immuno-Mycologics, Inc.
    Date Received
    August 23, 2011
    Decision Date
    March 28, 2012
    Product Code
    GMD
    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
    GMD Antisera, Latex Agglutination, Cryptococcus Neoformans

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    Other Clearances by Immuno-Mycologics, Inc.

    K Number Device Name
    K120946 ALPHA CRYPTOCOCCAL ANTIGEN EIA
    K102286 CRAG LATERAL FLOW ASSAY (CRAG LFA)
    K101407 ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
    K883333 RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
    K880029 EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001
    K843286 EI-CANDIDA ENZYME IMMUNOASSAY EI1001
    K831918 LA-STAPH IDENTIFICATION SYSTEM
    K830837 LA-HISTO ANTIBODY SYSTEM #HL 1001
    K810510 YA-CRYPTO ANTIBODY TUBE AGGLUTINATION
    K802427 LA-SPORO ANTIBODY SYSTEM
    Search all 26 clearances from Immuno-Mycologics, Inc. →