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

    INDICARD TEST

    K Number: K964015 · Decision Jun 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    255

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    Basic Information

    Device Name
    INDICARD TEST
    K Number
    K964015
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Litmus Concepts, Inc.
    Date Received
    October 7, 1996
    Decision Date
    June 19, 1997
    Product Code
    MJM
    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
    MJM Dna Probe, Gardnerella Vaginalis

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    Other Clearances by Litmus Concepts, Inc.

    K Number Device Name
    K962718 FEMEXAM TESTCARD