BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01

    K Number: K010892 · Decision Sep 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    9
    Review Days
    182

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    Basic Information

    Device Name
    MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
    K Number
    K010892
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Digene Corp.
    Date Received
    March 26, 2001
    Decision Date
    September 24, 2001
    Product Code
    LSK
    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
    LSK Dna-Reagents, Chlamydia

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    Other Clearances by Digene Corp.

    K Number Device Name
    K010891 MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
    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
    K974901 HYBRID CAPTURE SYSTEM CMV DNA ASSAY
    K980120 DIGENE DML 2000 MICROPLATE LUMINOMETER
    K971586 DIGENE CERVICAL BRUSH