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

    STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC

    K Number: K932912 · Decision Oct 28, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    91
    Applicant Total
    72
    Review Days
    134

    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
    STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
    K Number
    K932912
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1695
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    June 16, 1993
    Decision Date
    October 28, 1993
    Product Code
    CEC
    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
    CEC Radioimmunoassay, Free Thyroxine

    Similar 510(k) Clearances

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

    Access Free T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Elecsys FT4 IV

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAGLUMI 2000 FT4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Elecsys FT4 III

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Abbott Architect Free T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FREND™ Free T4 Test System

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

    Other Clearances by Baxter Diagnostics, Inc.

    K Number Device Name
    K934458 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K950817 DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
    K935704 DRIED GRAM-NEGATIVE MIC//COMBO PANELS
    K950570 STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
    K945235 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K941030 DRIED GRAM-NEGATIVE CEFPODOXIME
    K940917 LORACARBEF GRAM-NAGATIVE PANELS
    K941459 GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
    K941317 DRIED GRAM NEGATIVE/CEFMETAZOLE
    K942089 MICRODILUTION/LORACARBEF PANELS
    Search all 72 clearances from Baxter Diagnostics, Inc. →