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

    S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)

    K Number: K091413 · Decision Oct 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    229
    Applicant Total
    5
    Review Days
    166

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    Basic Information

    Device Name
    S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
    K Number
    K091413
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1175
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Wassermann, Inc.
    Date Received
    May 13, 2009
    Decision Date
    October 26, 2009
    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

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