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

    CHEMA CHOL CHOLESTEROL SYSTEM

    K Number: K904031 · Decision Mar 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    229
    Applicant Total
    10
    Review Days
    192

    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
    CHEMA CHOL CHOLESTEROL SYSTEM
    K Number
    K904031
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1175
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Texas Intl. Laboratories, Inc.
    Date Received
    August 31, 1990
    Decision Date
    March 11, 1991
    Product Code
    CHH
    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
    CHH Enzymatic Esterase--Oxidase, Cholesterol

    Similar 510(k) Clearances

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

    Lipids

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Cholesterol2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITROS XT Chemistry Products TRIG-CHOL Slides

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Extended Lipid Panel Assay

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Mission Lipid Panel Monitoring System

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

    Other Clearances by Texas Intl. Laboratories, Inc.

    K Number Device Name
    K953643 HEMATIL 18 (H-18)
    K900684 RDW AND MPV INDICES ON HEMAT 12
    K900685 CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER
    K884006 HEMAT 12
    K883177 H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER
    K853722 PLT-4 PLATELET ANALYZER
    K832886 FLAME PHOTOMETER T281-T282-T283
    K832890 HEMACOMP 7 OR HEMATIL 7
    K831649 THERMOMIXER S213-PHOTOANALYZER S263