BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TESTOK-125

    K Number: K800776 · Decision Apr 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    88
    Applicant Total
    20
    Review Days
    14

    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
    TESTOK-125
    K Number
    K800776
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1680
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    April 7, 1980
    Decision Date
    April 21, 1980
    Product Code
    CDZ
    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
    CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

    Similar 510(k) Clearances

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

    IDS-iSYS Total Testosterone

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IDS-iSYS Free Testosterone

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Access SHBG

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Access Testosterone

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Elecsys Testosterone II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON Testosterone xt

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Sorin Biomedica, Fiat, USA, Inc.

    K Number Device Name
    K931444 PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS
    K925661 STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
    K925369 BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
    K925615 SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE
    K924354 STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
    K925541 STOCKERT 1/4 BUBBLE SENSOR
    K922933 SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
    K854963 S80 IMPLANTABLE CARDIAC PACING LEAD
    K852641 ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
    K851365 SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
    Search all 20 clearances from Sorin Biomedica, Fiat, USA, Inc. →