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

    ENZYMATIC TRIGLYCERIDES REAGENT KIT

    K Number: K781240 · Decision Aug 17, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    150
    Applicant Total
    54
    Review Days
    28

    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
    ENZYMATIC TRIGLYCERIDES REAGENT KIT
    K Number
    K781240
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1705
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    J.T. Baker Chemical Co.
    Date Received
    July 20, 1978
    Decision Date
    August 17, 1978
    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 J.T. Baker Chemical Co.

    K Number Device Name
    K803128 SERIES 810 PLATELET ANALYZER
    K802080 BAKER DIAG. ULTRARATE CHLORIDE KIT
    K802035 BAKER DIAG. ULTRARATE CO2 REAGENT KIT
    K801909 LSA 290 ASSAY REAGENTS/NEPHELOMETRIC
    K801662 J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.
    K801669 J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO
    K801661 J.T. BAKER CERULOPLASMIN NEPHELOMETRIC
    K801795 BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.
    K801362 ALBUMIN NEPHELOMETRIC ASSAY
    K801432 HEMOPEXIN NEPHELOMETRIC ASSAY
    Search all 54 clearances from J.T. Baker Chemical Co. →