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

    THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS

    K Number: K123343 · Decision Jul 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    107
    Review Days
    253

    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
    THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
    K Number
    K123343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1678
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microgenics Corp.
    Date Received
    October 31, 2012
    Decision Date
    July 11, 2013
    Product Code
    MLM
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MLM Enzyme Immunoassay, Tracrolimus

    Similar 510(k) Clearances

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

    Tacrolimus Assay Kit

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Elecsys Tacrolimus

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ARCHITECT TACROLIMUS: MODEL 1L77

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MASSTRAK IMMUNOSUPPRESSANTS KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107

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

    Other Clearances by Microgenics Corp.

    K Number Device Name
    K122766 THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
    K123271 ABBOTT PHENOBARBITAL ASSAY
    K110616 THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
    K101742 THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
    K101744 THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
    K101752 THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
    K101746 THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
    K101753 THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
    K101754 THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
    K101745 THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
    Search all 107 clearances from Microgenics Corp. →