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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, detection, bacterial, for platelet transfusion products
510(k) Number BK050043
Tradename BacT/ALERT BPN Culture Bottle
Device Name System, Detection, Bacterial, Detection Systems for Platelet Transfusion Products
Original Applicant
bioMerieux, Inc.
100 rodolphe street
durham,  NC  27712
Regulation Number866.2560
Classification Product Code
MZC  
Date Received07/14/2005
Decision Date 12/27/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Immunology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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