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

    RADIOASSAY FOR TOTAL SERUM THYROXINE

    K Number: K780644 · Decision Apr 28, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    22
    Review Days
    11

    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
    RADIOASSAY FOR TOTAL SERUM THYROXINE
    K Number
    K780644
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nuclear Diagnostics, Inc.
    Date Received
    April 17, 1978
    Decision Date
    April 28, 1978
    Product Code
    CDX
    Advisory Committee
    Clinical Chemistry
    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
    CDX Radioimmunoassay, Total Thyroxine

    Similar 510(k) Clearances

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

    ELECSYS T4 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTIVE THYROXINE RIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELFIA NEONATAL THYROXINE KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AXSYM(TM) TOTAL T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO

    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. →