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

    IDI-MRSA ASSAY

    K Number: K042357 · Decision Oct 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    52

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    Basic Information

    Device Name
    IDI-MRSA ASSAY
    K Number
    K042357
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Infectio Diagnostic (I.D.I.), Inc.
    Date Received
    August 31, 2004
    Decision Date
    October 22, 2004
    Product Code
    NQX
    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
    NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

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    Other Clearances by Infectio Diagnostic (I.D.I.), Inc.

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