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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, blood culturing
510(k) Number K161816
Device Name BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
Applicant
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Jolyn Tenllado
Correspondent
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Jolyn Tenllado
Regulation Number866.2560
Classification Product Code
MDB  
Date Received07/01/2016
Decision Date 03/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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