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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 BK000042
Tradename BacT/ALERT Culture Bottles
Device Name System, Detection, Bacterial, Detection Systems for Platelet Transfusion Products
Original Applicant
bioMerieux, Inc.
100 akzo avenue
durham,  NC  27712
Regulation Number866.2560
Classification Product Code
MZC  
Date Received11/03/2000
Decision Date 02/15/2002
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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