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

    NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT

    K Number: K932406 · Decision Dec 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    22
    Review Days
    203

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    Basic Information

    Device Name
    NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
    K Number
    K932406
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1725
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nuclear Diagnostics, Inc.
    Date Received
    May 13, 1993
    Decision Date
    December 2, 1993
    Product Code
    JNO
    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
    JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin

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    Other Clearances by Nuclear Diagnostics, Inc.

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    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-
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    K810906 TRI-LEVEL NDI CONTROL
    Search all 22 clearances from Nuclear Diagnostics, Inc. →