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

    DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO

    K Number: K792183 · Decision Nov 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    79
    Applicant Total
    44
    Review Days
    15

    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
    DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
    K Number
    K792183
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Dade, Baxter Travenol Diagnostics, Inc.
    Date Received
    October 29, 1979
    Decision Date
    November 13, 1979
    Product Code
    LBS
    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
    LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

    Similar 510(k) Clearances

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

    HDL-Cholesterol Gen.4

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Direct HDL Cholesterol (HDL)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITROS CHEMISTRY PRODUCTS DHDL SLIDES

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NMR LIPOPROFILE (R) TEST AND NMR PROFILER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS

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

    Other Clearances by Dade, Baxter Travenol Diagnostics, Inc.

    K Number Device Name
    K800296 WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
    K792606 WHOLE BLOOD PLATELET CONTROL NORMAL,
    K792723 BLOOD FLUID FILTERS
    K792607 T3 UPTAKE (T3U) REAGENTS
    K792443 TSH RADIOIMMUNOASSAY
    K792442 FERRITIN RADIOIMMUNOASSAY
    K791922 HARLECO BRAND CLINICARD LIPASE TEST SET
    K790767 IMMU-TEK AUTOMATIC CENTRIFUGE
    K790776 DADE LOW IONIC STRENGTH SOLUITION (LISS)
    K790571 QUIK-STAIN
    Search all 44 clearances from Dade, Baxter Travenol Diagnostics, Inc. →