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

    OPTIMATE DIGOXIN TEST

    K Number: K853021 · Decision Aug 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    9
    Applicant Total
    158
    Review Days
    20

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    Basic Information

    Device Name
    OPTIMATE DIGOXIN TEST
    K Number
    K853021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Miles Laboratories, Inc.
    Date Received
    July 18, 1985
    Decision Date
    August 7, 1985
    Product Code
    DPB
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPB Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DPB), ordered by most recent decision date.

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    DIGOXIN RADIOIMMUNOASSAY

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    RIA, DIGNXIN-125-I

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    RIA TEST KIT, CENTRIA DIGOXIN

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    FDA Class 2 ·Clinical Toxicology
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