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

    TIPSEP DIGOXIN RIA

    K Number: K852291 · Decision Jun 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    22
    Review Days
    27

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    Basic Information

    Device Name
    TIPSEP DIGOXIN RIA
    K Number
    K852291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Nuclear Diagnostics, Inc.
    Date Received
    May 29, 1985
    Decision Date
    June 25, 1985
    Product Code
    DNL
    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
    DNL Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.

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    K862312 ENZLIPASE, ENZYMATIC LIPASE KIT
    K860472 NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
    K861735 TIPSEP-TBG ASSAY
    K833713 SERUM THYROTROPIN ASSAY KIT, TIPSEP-
    K823860 NUCLIPASE (I125) PANCREATIC LIPASE
    K811558 TSH-P.E.G.
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