BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HEPATITIS NEGATIVE CONTROL

    K Number: K962399 · Decision Aug 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    0
    Applicant Total
    12
    Review Days
    42

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    Basic Information

    Device Name
    HEPATITIS NEGATIVE CONTROL
    K Number
    K962399
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pyramid Biological Corp.
    Date Received
    June 21, 1996
    Decision Date
    August 2, 1996
    Product Code
    MJY
    Advisory Committee
    Clinical Chemistry
    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
    MJY Kit, Serological, Negative Control

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