FLUID SAMPLE RETRIEVAL SYSTEM


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

Correspodent Contact susan b fentress
Regulation Number 862.1675
Classification Product Code
JKA  
Date Received 02/05/2003
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