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

    AI-PHOTODIAGNOSTIC

    K Number: K940004 · Decision Aug 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    578

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    Basic Information

    Device Name
    AI-PHOTODIAGNOSTIC
    K Number
    K940004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1085
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pharmarceutical Discovery Corp.
    Date Received
    January 3, 1994
    Decision Date
    August 4, 1995
    Product Code
    CIB
    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
    CIB Radioimmunoassay, Angiotensin I And Renin

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