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510(k) K161816

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO by bioMerieux, Inc. — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2017
Date Received
July 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Blood Culturing
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type

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