BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT

    K Number: K880665 · Decision Mar 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    104
    Applicant Total
    2
    Review Days
    12

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    Basic Information

    Device Name
    MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT
    K Number
    K880665
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Allelix Diagnostics, Inc.
    Date Received
    February 18, 1988
    Decision Date
    March 1, 1988
    Product Code
    GTZ
    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
    GTZ Antisera, All Groups, Streptococcus Spp.

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