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

    HYBRID CAPTURE SYSTEM CMV DNA ASSAY

    K Number: K974901 · Decision Sep 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    9
    Review Days
    272

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    Basic Information

    Device Name
    HYBRID CAPTURE SYSTEM CMV DNA ASSAY
    K Number
    K974901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Digene Corp.
    Date Received
    December 31, 1997
    Decision Date
    September 29, 1998
    Product Code
    LJO
    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
    LJO Antigen, Iha, Cytomegalovirus

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    Other Clearances by Digene Corp.

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    K010893 MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
    K981567 HYBRID CAPTURE II CT/GC TEST
    K981485 HYBRID CAPTURE II GC-ID
    K990023 HYBRID CAPTURE II CT-ID TEST
    K980120 DIGENE DML 2000 MICROPLATE LUMINOMETER
    K971586 DIGENE CERVICAL BRUSH