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510(k) K203336

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 by Oxoid Limited (Part of Thermo Fisher Scientific) — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2022
Date Received
November 12, 2020
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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  • K210873 — Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 (October 27, 2021)
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  • K193508 — Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 (December 4, 2020)
  • K181975 — Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 (September 27, 2018)

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