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

    TIPSEP-TBG ASSAY

    K Number: K861735 · Decision Jun 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    24
    Applicant Total
    22
    Review Days
    38

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    Basic Information

    Device Name
    TIPSEP-TBG ASSAY
    K Number
    K861735
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1685
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nuclear Diagnostics, Inc.
    Date Received
    May 6, 1986
    Decision Date
    June 13, 1986
    Product Code
    CEE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CEE Radioimmunoassay, Thyroxine-Binding Globulin

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    Other Clearances by Nuclear Diagnostics, Inc.

    K Number Device Name
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    K932406 NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
    K872177 TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
    K862312 ENZLIPASE, ENZYMATIC LIPASE KIT
    K860472 NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
    K852291 TIPSEP DIGOXIN RIA
    K833713 SERUM THYROTROPIN ASSAY KIT, TIPSEP-
    K823860 NUCLIPASE (I125) PANCREATIC LIPASE
    K811558 TSH-P.E.G.
    K810906 TRI-LEVEL NDI CONTROL
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