BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    TRIGLYCERIDES TEST KIT

    K Number: K895952 · Decision Jan 11, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    150
    Applicant Total
    5
    Review Days
    92

    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
    TRIGLYCERIDES TEST KIT
    K Number
    K895952
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1705
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Elite Technology, Inc.
    Date Received
    October 11, 1989
    Decision Date
    January 11, 1990
    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

    ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OLYMPUS TRIGLYCERIDE TEST SYSTEM

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

    Other Clearances by Elite Technology, Inc.

    K Number Device Name
    K900733 PROTEIN TEST FOR URINE AND CSF
    K901001 URIC ACID TEST KIT
    K901090 ELITECH GAMMA GT TEST KIT
    K895951 CHOLESTEROL TEST KIT