HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)— 510(k) K250454

Name: FDA 510(k) clearance K250454
Creator: U.S. Food and Drug Administration
Published: 2025-05-15

Substantially Equivalent

Hardy Diagnostics

FDA 510(k) clearance K250454 for HardyDisk Aztreonam/Avibactam 30/20µg (AZA50), Substantially Equivalent on 2025-05-15. Applicant: Hardy Diagnostics. Device class: 2.

Clearance details

Applicant: Hardy Diagnostics
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 2025-02-18
Decision date: 2025-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

Download summary PDF View on FDA.gov ↗

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K233534 — Viral Transport Medium2024-08-02
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Data sourced from openFDA. This site is unofficial and independent of the FDA.