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

    DIGOXIN RADIOIMMUNOASSAY KIT

    K Number: K801202 · Decision Jun 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    14
    Applicant Total
    9
    Review Days
    32

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    Basic Information

    Device Name
    DIGOXIN RADIOIMMUNOASSAY KIT
    K Number
    K801202
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Technia Diagnostics , Ltd.
    Date Received
    May 19, 1980
    Decision Date
    June 20, 1980
    Product Code
    LCS
    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
    LCS Radioimmunoassay, Digoxin (125-I)

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    K790919 HPL RIA KIT
    K790495 THYROXINE RIA KIT
    K782024 RIA KIT, VITAMIN B12
    K782025 GENTAMICIN FLUROIMMUNASSAY KIT