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

    CHOLESTEROL DET. IN SERUM

    K Number: K781611 · Decision Oct 24, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    89
    Review Days
    35

    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 DET. IN SERUM
    K Number
    K781611
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1175
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Fisher Scientific Co., LLC
    Date Received
    September 19, 1978
    Decision Date
    October 24, 1978
    Product Code
    CGO
    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
    CGO Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol

    Similar 510(k) Clearances

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

    CHOLESTEROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KING DIAGNOSTICS CHOLESTEROL TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CHOLESTEROL REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    REAGENTS FOR DETERM. CHOLESTEROL/SERUM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SR-PLUS DIRECT CHOLESTEROL TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ALPHA/CHOL

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

    Other Clearances by Fisher Scientific Co., LLC

    K Number Device Name
    K930415 MICROHEMATOCRIT ROTOR
    K915825 MARATHON 6K GENERAL-PURPOSE CENTRIFUGE
    K915441 MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE
    K890534 MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
    K881275 URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II
    K874054 FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
    K872916 HISTOMATIC SLIDE STAINER, CODE-ON VERSION
    K871058 SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN)
    K863224 HEMATALL-C PLUS HEMATOLOGY CONTROLS
    K862318 FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR
    Search all 89 clearances from Fisher Scientific Co., LLC →