BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TRIGLYCERIDE AQUEOUS STANDARDS

    K Number: K840218 · Decision Mar 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    18
    Review Days
    64

    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
    TRIGLYCERIDE AQUEOUS STANDARDS
    K Number
    K840218
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Preventive Diagnostics Corp.
    Date Received
    January 19, 1984
    Decision Date
    March 23, 1984
    Product Code
    JIT
    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
    JIT Calibrator, Secondary

    Similar 510(k) Clearances

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

    VITROS Immunodiagnostic Products Insulin Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CalSet IGF-1

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Abbott ARCHITECT Free T3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Lumipulse G Progesterone-N Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Lumipulse G FSH-N Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Lumipulse G LH Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Preventive Diagnostics Corp.

    K Number Device Name
    K840677 HDL EZ-TZ3 CHOLESTEROL REAGENT KIT
    K840676 PDC HDL EZ-SEP CHOLESTEROL REAGENT
    K840278 HDL CHOLESTEROL CONTROLS-LEVELS
    K840990 PRESERV CARY BLAIR TRANSPORT PACK
    K840220 HDL CHOLESTEROL AQUEOUS STANDARDS
    K840189 TOTAL CHOLESTEROL REAGENT SET
    K840219 TRIGLYCERIDE/CHOLESTEROL AQUEOUS
    K840991 PRESERV BUFFERED GLYCEROL SALINE
    K840968 PRESERV TRANSPORT & CULTURE PACK
    K840217 CHOLESTEROL AQUEOUS STANDARD
    Search all 18 clearances from Preventive Diagnostics Corp. →