BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NUCLIPASE (I125) PANCREATIC LIPASE

    K Number: K823860 · Decision Apr 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    22
    Review Days
    117

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    Basic Information

    Device Name
    NUCLIPASE (I125) PANCREATIC LIPASE
    K Number
    K823860
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1465
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nuclear Diagnostics, Inc.
    Date Received
    December 22, 1982
    Decision Date
    April 18, 1983
    Product Code
    CET
    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
    CET Olive Oil Emulsion (Turbidimetric), Lipase

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    Other Clearances by Nuclear Diagnostics, Inc.

    K Number Device Name
    K923917 ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY
    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
    K861735 TIPSEP-TBG ASSAY
    K852291 TIPSEP DIGOXIN RIA
    K833713 SERUM THYROTROPIN ASSAY KIT, TIPSEP-
    K811558 TSH-P.E.G.
    K810906 TRI-LEVEL NDI CONTROL
    Search all 22 clearances from Nuclear Diagnostics, Inc. →