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

    PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS

    K Number: K920378 · Decision Apr 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    62
    Review Days
    91

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    Basic Information

    Device Name
    PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
    K Number
    K920378
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gen-Probe, Inc.
    Date Received
    January 29, 1992
    Decision Date
    April 29, 1992
    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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