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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name system, detection, bacterial, for platelet transfusion products
510(k) Number BK170142
Tradenames BacT/ALERT® BPA Culture Bottle, BacT/ALERT® BPN Culture Bottle
Device Name System, Detection, Bacterial, Detection Systems for Platelet Transfusion Products
Original Applicant
bioMerieux, Inc.
595 anglum road
hazelwood,  MO  63042
Regulation Number866.2560
Classification Product Code
MZC  
Date Received11/03/2017
Decision Date 02/01/2018
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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