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510(k) K193508

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 by Oxoid Limited (Part of Thermo Fisher Scientific) — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2020
Date Received
December 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type

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