ETEST Delafloxacin (DFX) (0.002-32 µg/mL)— 510(k) K192738

Substantially Equivalent

Biomerieux S.A.

FDA 510(k) clearance K192738 for ETEST Delafloxacin (DFX) (0.002-32 µg/mL), Substantially Equivalent on 2019-11-26. Applicant: Biomerieux S.A..

Clearance details

Applicant
Biomerieux S.A.
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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