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

    QLT ABSOLUTE URINE-HCG PREGNANCY TEST

    K Number: K881806 · Decision Aug 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    1
    Review Days
    96

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    Basic Information

    Device Name
    QLT ABSOLUTE URINE-HCG PREGNANCY TEST
    K Number
    K881806
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Quadra Logic Technologies, Inc.
    Date Received
    April 28, 1988
    Decision Date
    August 2, 1988
    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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