ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)— 510(k) K250856

Substantially Equivalent

Biomérieux

FDA 510(k) clearance K250856 for ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL), Substantially Equivalent on 2025-06-12. Applicant: Biomérieux.

Clearance details

Applicant: Biomérieux
Product code: Code JWY
Advisory panel: Microbiology
Date received: 2025-03-21
Decision date: 2025-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marcy-L'Etoile, FR

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