BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT

    K Number: K871308 · Decision Jun 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT
    K Number
    K871308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Allelix, Inc.
    Date Received
    April 1, 1987
    Decision Date
    June 11, 1987
    Product Code
    JHI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Allelix, Inc.

    K Number Device Name
    K871620 ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT