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

    AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY

    K Number: K070174 · Decision Apr 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY
    K Number
    K070174
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corporation
    Date Received
    January 18, 2007
    Decision Date
    April 16, 2007
    Product Code
    MKZ
    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
    MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia

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    Other Clearances by Roche Diagnostics Corporation

    K Number Device Name
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    K112528 ELECSYS T4 CALCHECK 5
    K070172 AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE