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510(k) Data Aggregation

    K Number
    K030394
    Device Name
    FLUID SAMPLE RETRIEVAL SYSTEM
    Date Cleared
    2003-10-27

    (264 days)

    Product Code
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Personal Fluid Sample Retrieval System is for over-the-counter distribution and is a device for collection and transportation of serum for in vitro diagnostic quantitative determination of cholesterol, triglycerides, glucose, HDL cholesterol and calculated LDL cholesterol. The serum sample is transferred in a transport pouch to the testing laboratory and results are returned directly to the consumer.
    Device Description
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    K Number
    K030076
    Device Name
    PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM
    Date Cleared
    2003-07-07

    (180 days)

    Product Code
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Professional Blood Sample Retrieval System is for use by a medical, dental, chiropractic, podiatric or physician's office and is a device for collection and transportation of serum for in vitro diagnostic quantitative determination to include albumin, alkaline phosphatase, bilirubin, blood urea nitrogen. calcium, chloride, cholesterol, creatinine, gamma-glutamyl transaminase (GGT), globulin, glucose, HDL cholesterol (good), LDL cholesterol (bad), lactic dehydrogenase, phosphorous, potassium, protein - total, sodium, serum gamma-oxaloacetic transaminase (SGOT), serum glutamate-pyruvate transaminase (SGPT), triglycerides, uric acid, lipid panel: cholesterol, HDL (good) cholesterol, LDL (bad) cholesterol, triglycerides; thyroid panel: Thyroxine, Total (T4), triiodothyroxine (T3), thyroid stimulating hormone (TSH): and iron. The serum sample is transferred in a transport pouch to the testing laboratory and results are returned to the ordering physician.
    Device Description
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