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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K030394
Device Name FLUID SAMPLE RETRIEVAL SYSTEM
Applicant
Biomed Personal Metabolic and Nutritional Testing
6075 Poplar Ave., Suite 500
Memphis,  TN  38119
Applicant Contact SUSAN B FENTRESS
Correspondent
Biomed Personal Metabolic and Nutritional Testing
6075 Poplar Ave., Suite 500
Memphis,  TN  38119
Correspondent Contact SUSAN B FENTRESS
Regulation Number862.1675
Classification Product Code
JKA  
Date Received02/05/2003
Decision Date 10/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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