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

    CHOLESTEROL REAGENT SUBSTRATE SET

    K Number: K781970 · Decision Jan 3, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    111
    Review Days
    40

    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
    CHOLESTEROL REAGENT SUBSTRATE SET
    K Number
    K781970
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Corning Medical & Scientific
    Date Received
    November 24, 1978
    Decision Date
    January 3, 1979
    Product Code
    JHO
    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
    JHO Electrophoretic Separation, Lipoproteins

    Similar 510(k) Clearances

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

    SPIFE LIPPOROTEIN-12, MODEL 3344

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIPOPRINT SYSTEM, LDL SUBFRACTIONS

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

    Other Clearances by Corning Medical & Scientific

    K Number Device Name
    K875122 DISPOSABLE STERILE SYRINGE FILTERS
    K872273 CORNING EASY WASH ELISA PLATES
    K872076 CORNING DISPOSABLE ROLLER BOTTLES
    K863789 CORNING ELISA PLATES
    K854024 CORNING MAGIC MAB HCG RADIOIMMUNOASSAY
    K853634 CORNING CELL WELLS-MULTIPLE WELL PLATES
    K851939 CORNING CERTAIN -ISE
    K851329 MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA
    K850806 CORNING BLOOD COLLECTION CAPILLARY TUBES
    K850617 CORNING 780 FLUOROMETER/DENSITOMETER
    Search all 111 clearances from Corning Medical & Scientific →