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

    i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials

    K Number: K133002 · Decision Apr 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    71
    Applicant Total
    20
    Review Days
    569

    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
    i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
    K Number
    K133002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Point of Care, Inc.
    Date Received
    September 24, 2013
    Decision Date
    April 16, 2015
    Product Code
    DHA
    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
    DHA System, Test, Human Chorionic Gonadotropin

    Similar 510(k) Clearances

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

    VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Alinity i Total ß-hCG Reagent Kit, GLP systems Track

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Access Total ßhCG (5th IS)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

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

    Other Clearances by Abbott Point of Care, Inc.

    K Number Device Name
    K253051 i-STAT hs-TnI cartridge with the i-STAT Alinity System
    K244014 i-STAT CG4+ cartridge with the i-STAT 1 System
    K240984 i-STAT hs-TnI cartridge with the i-STAT 1 System
    K230275 i-STAT CG8+ cartridge with the i-STAT 1 System
    K230285 i-STAT CG8+ cartridge with the i-STAT 1 System
    K230300 i-STAT CG8+ cartridge with the i-STAT 1 System
    K223857 i-STAT G3+ cartridge with the i-STAT 1 System
    K223755 i-STAT G cartridge with the i-STAT 1 System
    K223710 i-STAT CG8+ cartridge with the i-STAT 1 System
    K210958 i-STAT CHEM8+ cartridge with the i-STAT 1 System
    Search all 20 clearances from Abbott Point of Care, Inc. →