Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50

FDA 510(k) K250789 · Thermo Fisher Scientific (Oxoid Ltd.)

Substantially Equivalent

510(k) numberK250789

Submission

Device name
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
Applicant
Thermo Fisher Scientific (Oxoid Ltd.)
Basingstoke, GB
Received
March 14, 2025
Decision date
June 12, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JTN – Susceptibility Test Discs, Antimicrobial
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1620
Specialty
Microbiology

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K250956HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional Hardy Diagnostics06/26/2025SE
K250885Ceftobiprole BPR 5 µg DiscJTN · Traditional Liofilchem, Inc.06/23/2025SE
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More from Hardy Diagnostics

510(k)DeviceDecision
K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60JTN · Traditional 07/24/2026SE
K251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10JTN · Traditional 12/05/2025SE

Questions and answers

When was Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 cleared by the FDA?

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 (K250789) received a 510(k) decision of Substantially Equivalent on June 12, 2025, 90 days after the submission was received.

What is the product code of K250789?

The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.