ETEST Plazomicin (PLZ) (0.016-256 µg/mL)— 510(k) K200512
Substantially EquivalentBiomérieux SA
FDA 510(k) clearance K200512 for ETEST Plazomicin (PLZ) (0.016-256 µg/mL), Substantially Equivalent on 2020-05-07. Applicant: Biomérieux SA.
Clearance details
- Applicant
- Biomérieux SA
- Product code
- Code JWY
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marcy-L'Etoile, FR
Data sourced from openFDA. This site is unofficial and independent of the FDA.