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

    FLUID SAMPLE RETRIEVAL SYSTEM

    K Number: K030394 · Decision Oct 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    2
    Review Days
    264

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    Basic Information

    Device Name
    FLUID SAMPLE RETRIEVAL SYSTEM
    K Number
    K030394
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biomed Personal Metabolic and Nutritional Testing
    Date Received
    February 5, 2003
    Decision Date
    October 27, 2003
    Product Code
    JKA
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Biomed Personal Metabolic and Nutritional Testing

    K Number Device Name
    K030076 PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM