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

    STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY

    K Number: K860421 · Decision Feb 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    149
    Review Days
    7

    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
    STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
    K Number
    K860421
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Dade
    Date Received
    February 4, 1986
    Decision Date
    February 11, 1986
    Product Code
    CDX
    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
    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 American Dade

    K Number Device Name
    K873051 STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
    K873171 STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
    K873052 STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
    K872789 PARAMAX URINE/CSF CALIBRATOR
    K872195 DATA-FI DIMERTEST LATEX ASSAY
    K872196 AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
    K871972 STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY
    K871977 DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR
    K872050 PARAMAX CHOLESTEROL REAGENT
    K872360 DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
    Search all 149 clearances from American Dade →