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

    HYBRID CAPTURE II CT-ID TEST

    K Number: K990023 · Decision Oct 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    9
    Review Days
    293

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    Basic Information

    Device Name
    HYBRID CAPTURE II CT-ID TEST
    K Number
    K990023
    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
    January 5, 1999
    Decision Date
    October 25, 1999
    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
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    K010892 MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
    K010893 MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
    K981567 HYBRID CAPTURE II CT/GC TEST
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    K974901 HYBRID CAPTURE SYSTEM CMV DNA ASSAY
    K980120 DIGENE DML 2000 MICROPLATE LUMINOMETER
    K971586 DIGENE CERVICAL BRUSH