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

    ACCESS TOTAL BHCG ASSAY (MODIFICATION)

    K Number: K954732 · Decision Nov 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    82
    Review Days
    49

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    Basic Information

    Device Name
    ACCESS TOTAL BHCG ASSAY (MODIFICATION)
    K Number
    K954732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories, Inc.
    Date Received
    October 2, 1995
    Decision Date
    November 20, 1995
    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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