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

    ALADIN (TM)

    K Number: K865062 · Decision Mar 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    44
    Applicant Total
    57
    Review Days
    91

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    Basic Information

    Device Name
    ALADIN (TM)
    K Number
    K865062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Analytical Products, Inc.
    Date Received
    December 24, 1986
    Decision Date
    March 25, 1987
    Product Code
    LRG
    Advisory Committee
    Microbiology
    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
    LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

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