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510(k) K250789

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 by Thermo Fisher Scientific (Oxoid Ltd.) — Product Code JTN

K250789 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific (Oxoid Ltd.) for the device "Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50". The FDA issued a decision of Substantially Equivalent on June 12, 2025. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Thermo Fisher Scientific (Oxoid Ltd.) has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2025
Date Received
March 14, 2025
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

Other clearances by Thermo Fisher Scientific (Oxoid Ltd.)

  • K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 (December 5, 2025)

Other clearances for product code JTN

  • K260842 — HardyDisk AST Gepotidacin 10µg (GEP10) (May 11, 2026)
  • K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 (December 5, 2025)
  • K253105 — HardyDisk AST Cefiderocol 30µg (FDC30) (November 20, 2025)
  • 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)
  • 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)

FDA data resources