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

    DIGOXIN RIA (PEG) KIT

    K Number: K781335 · Decision Aug 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    24
    Review Days
    29

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    Basic Information

    Device Name
    DIGOXIN RIA (PEG) KIT
    K Number
    K781335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostics, Inc.
    Date Received
    August 2, 1978
    Decision Date
    August 31, 1978
    Product Code
    DOG
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DOG Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol

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