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

    S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022

    K Number: K091333 · Decision Aug 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    30
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
    K Number
    K091333
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Wassermann, Inc.
    Date Received
    May 6, 2009
    Decision Date
    August 3, 2009
    Product Code
    MRR
    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
    MRR System, Test, Low Density, Lipoprotein

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    Other Clearances by Alfa Wassermann, Inc.

    K Number Device Name
    K091413 S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
    K091544 S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
    K080073 S-TEST CREATININE (CRE)
    K063306 ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72