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

    ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL

    K Number: K102993 · Decision May 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    150
    Applicant Total
    6
    Review Days
    223

    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
    ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
    K Number
    K102993
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1705
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seppim S.A.S.
    Date Received
    October 8, 2010
    Decision Date
    May 19, 2011
    Product Code
    CDT
    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
    CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

    Similar 510(k) Clearances

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

    Triglycerides

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITROS CHEMISTRY PRODUCTS TRIG SLIDES

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VANTERA CLINICAL ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OLYMPUS TRIGLYCERIDE TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE

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

    Other Clearances by Seppim S.A.S.

    K Number Device Name
    K103376 ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
    K100547 ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
    K100263 ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
    K100525 ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
    K093883 AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-