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

    HDL CHOLESTEROL AQUEOUS STANDARDS

    K Number: K840220 · Decision Mar 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    129
    Applicant Total
    18
    Review Days
    64

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    Basic Information

    Device Name
    HDL CHOLESTEROL AQUEOUS STANDARDS
    K Number
    K840220
    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
    JIS
    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
    JIS Calibrator, Primary

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    Other Clearances by Preventive Diagnostics Corp.

    K Number Device Name
    K840677 HDL EZ-TZ3 CHOLESTEROL REAGENT KIT
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    K840218 TRIGLYCERIDE AQUEOUS STANDARDS
    K840278 HDL CHOLESTEROL CONTROLS-LEVELS
    K840990 PRESERV CARY BLAIR TRANSPORT PACK
    K840189 TOTAL CHOLESTEROL REAGENT SET
    K840219 TRIGLYCERIDE/CHOLESTEROL AQUEOUS
    K840991 PRESERV BUFFERED GLYCEROL SALINE
    K840968 PRESERV TRANSPORT & CULTURE PACK
    K840217 CHOLESTEROL AQUEOUS STANDARD
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