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

    ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT

    K Number: K871620 · Decision Jun 17, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    104
    Applicant Total
    2
    Review Days
    51

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    Basic Information

    Device Name
    ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT
    K Number
    K871620
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Allelix, Inc.
    Date Received
    April 27, 1987
    Decision Date
    June 17, 1987
    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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    Other Clearances by Allelix, Inc.

    K Number Device Name
    K871308 ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT