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

    HYBRID CAPTURE II GC-ID

    K Number: K981485 · Decision Nov 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    44
    Applicant Total
    9
    Review Days
    584

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    Basic Information

    Device Name
    HYBRID CAPTURE II GC-ID
    K Number
    K981485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Digene Corp.
    Date Received
    April 24, 1998
    Decision Date
    November 29, 1999
    Product Code
    LSL
    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
    LSL Dna-Reagents, Neisseria

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    Other Clearances by Digene Corp.

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    K981567 HYBRID CAPTURE II CT/GC TEST
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    K974901 HYBRID CAPTURE SYSTEM CMV DNA ASSAY
    K980120 DIGENE DML 2000 MICROPLATE LUMINOMETER
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