MTS Eravacycline 0.002 - 32 µg/mL— 510(k) K182557
Substantially EquivalentLiofilchem s.r.l.
FDA 510(k) clearance K182557 for MTS Eravacycline 0.002 - 32 µg/mL, Substantially Equivalent on 2018-11-02. Applicant: Liofilchem s.r.l.. Device class: 2.
Clearance details
- Applicant
- Liofilchem s.r.l.
- Product code
- Code JWY
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roseto Degli Abruzzi, IT
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More clearances from Liofilchem s.r.l.
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