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

    STIKSEP-T3 KIT

    K Number: K780486 · Decision Apr 28, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    24
    Applicant Total
    22
    Review Days
    32

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    STIKSEP-T3 KIT
    K Number
    K780486
    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
    March 27, 1978
    Decision Date
    April 28, 1978
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CEE), ordered by most recent decision date.

    AMERLITE TBG ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCESS THYROID UPTAKE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMMULITE(TM) T-UPTAKE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELFIA TBG KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENZYMUN TEST(R) TBK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    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-
    K823860 NUCLIPASE (I125) PANCREATIC LIPASE
    K811558 TSH-P.E.G.
    Search all 22 clearances from Nuclear Diagnostics, Inc. →