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510(k) K172708

T2Bacteria Panel by T2biosystems, Inc. — Product Code QBX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 24, 2018
Date Received: September 8, 2017
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Direct Blood Bacterial Nucleic Acid Detection System
Device Class: Class II
Regulation Number: 866.3960
Review Panel: MI
Submission Type

Amplification, detection and identification of microbial pathogens directly from whole blood specimens