BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OPUS (TM) HCG

    K Number: K901935 · Decision Jun 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    35
    Review Days
    57

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    Basic Information

    Device Name
    OPUS (TM) HCG
    K Number
    K901935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Pb Diagnostic Systems, Inc.
    Date Received
    April 30, 1990
    Decision Date
    June 26, 1990
    Product Code
    JHI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    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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