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

    MMS T4 RIA KIT

    K Number: K861320 · Decision Apr 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    42
    Review Days
    16

    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
    MMS T4 RIA KIT
    K Number
    K861320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Micromedic Systems
    Date Received
    April 8, 1986
    Decision Date
    April 24, 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 Micromedic Systems

    K Number Device Name
    K923643 MEDICOOL
    K872309 MICROMEDIC COMBOSTAT LH/FSH KIT
    K871505 AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT
    K871008 MICROMEDIC NEONATAL T4 KIT
    K870904 MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT
    K870245 AUTOPAK TSH MONOCLONAL IRMA KIT
    K862206 TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER
    K860813 MICROMEDIC HTSH MONOCLONAL IRMA KIT
    K861262 MMS T3 UPTAKE
    K853127 MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
    Search all 42 clearances from Micromedic Systems →