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

    MYCOAKT M KANSASII CULTURE ID KIT

    K Number: K943050 · Decision Mar 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    259

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    Basic Information

    Device Name
    MYCOAKT M KANSASII CULTURE ID KIT
    K Number
    K943050
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dynagen, Inc.
    Date Received
    June 27, 1994
    Decision Date
    March 13, 1995
    Product Code
    JSY
    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
    JSY Kit, Identification, Mycobacteria

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    Other Clearances by Dynagen, Inc.

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    K943051 MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT
    K931105 PROCHECK(TM) BLIND PERFORMANCE SPECIMENS
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