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

    IVD CRYPTO/GIARDIA DFA

    K Number: K024113 · Decision Mar 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    26
    Applicant Total
    5
    Review Days
    82

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    Basic Information

    Device Name
    IVD CRYPTO/GIARDIA DFA
    K Number
    K024113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ivd Research, Inc.
    Date Received
    December 13, 2002
    Decision Date
    March 5, 2003
    Product Code
    MHI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MHI Giardia Spp.

    Similar 510(k) Clearances

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

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    XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020

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    XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY

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    GIARDIA II

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    FDA Class 2 ·Microbiology
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    Other Clearances by Ivd Research, Inc.

    K Number Device Name
    K081064 GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
    K032897 C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96
    K031059 IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
    K020583 IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96