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

    TOTAL LIPIDS

    K Number: K863073 · Decision Sep 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    34
    Review Days
    28

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    Basic Information

    Device Name
    TOTAL LIPIDS
    K Number
    K863073
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1470
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    J. D. Assoc.
    Date Received
    August 12, 1986
    Decision Date
    September 9, 1986
    Product Code
    CFD
    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
    CFD Sulfophosphovanillin, Colorimetry, Total Lipids

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    Other Clearances by J. D. Assoc.

    K Number Device Name
    K863103 PEG 6,000
    K863054 AST S.C.E. (GOT)
    K863069 MAGNESIOMETER
    K863079 CREATINKINETIC
    K863112 PROTEINMETER
    K863068 LDH S.C.E.
    K863053 ALT S.C.E. (GPT)
    K863066 TRANSFERMETER
    K863109 FERROFAST
    K863102 GLUCOMETER-E
    Search all 34 clearances from J. D. Assoc. →