ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD— 510(k) K232395

Substantially Equivalent

Biomérieux

FDA 510(k) clearance K232395 for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD, Substantially Equivalent on 2023-10-05. Applicant: Biomérieux.

Clearance details

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