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

    ALPHA CRYPTOCOCCAL ANTIGEN EIA

    K Number: K120946 · Decision Dec 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    26
    Review Days
    263

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    Basic Information

    Device Name
    ALPHA CRYPTOCOCCAL ANTIGEN EIA
    K Number
    K120946
    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
    March 29, 2012
    Decision Date
    December 17, 2012
    Product Code
    MDU
    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
    MDU Antigen, Elisa, Cryptococcus

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    Other Clearances by Immuno-Mycologics, Inc.

    K Number Device Name
    K112422 CRAG LATERAL FLOW ASSAY (LFA)
    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. →