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

    CEDIA SIROLIMUS ASSAY

    K Number: DEN040008 · Decision Jul 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    4
    Applicant Total
    107
    Review Days
    41

    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
    CEDIA SIROLIMUS ASSAY
    K Number
    DEN040008
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    862.3840
    Medical Specialty
    Clinical Toxicology
    Decision
    Unknown
    Applicant
    Microgenics Corp.
    Date Received
    June 17, 2004
    Decision Date
    July 28, 2004
    Product Code
    NRP
    Advisory Committee
    Clinical Toxicology
    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
    NRP Sirolimus Test System

    Similar 510(k) Clearances

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

    EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ARCHITECT SIROLIMUS ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY

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

    Other Clearances by Microgenics Corp.

    K Number Device Name
    K122766 THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
    K123343 THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
    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
    Search all 107 clearances from Microgenics Corp. →