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

    ADVANCE DIAGNOSTICS DISPOSABLE EYECUP

    K Number: K881369 · Decision May 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    10
    Review Days
    42

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    Basic Information

    Device Name
    ADVANCE DIAGNOSTICS DISPOSABLE EYECUP
    K Number
    K881369
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Advantage Diagnostics Corp.
    Date Received
    April 1, 1988
    Decision Date
    May 13, 1988
    Product Code
    LXQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LXQ Cup, Eye

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    Other Clearances by Advantage Diagnostics Corp.

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    K011962 ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
    K010921 ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
    K003708 ADVANTAGE THC/COCAINE TEST
    K001567 ADVANTAGE THC TEST
    K994227 ADVANTAGE HCG TEST (URINE/SERUM)
    K991883 REDI-TEST OPIATES
    K903416 CANNULA, SURGICAL