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510(k) K203700

Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 by Oxoid Limited (Part of Thermo Fisher Scientific) — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2021
Date Received
December 18, 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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  • K203336 — Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 (September 15, 2022)
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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)

Other clearances for product code JTN

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  • K251879 — Sulopenem SPM 2 µg (August 12, 2025)
  • K250956 — HardyDisk AST Gepotidacin 10µg (GEP10) (June 26, 2025)
  • K250885 — Ceftobiprole BPR 5 µg Disc (June 23, 2025)
  • K250789 — Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 (June 12, 2025)
  • K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (May 15, 2025)
  • K241060 — HardyDisk AST Cefiderocol 30µg (FDC30) (July 18, 2024)
  • K231806 — Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 (March 22, 2024)
  • K232276 — Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 (October 6, 2023)