Gepotidacin GEP 10 µg— 510(k) K261853
Substantially EquivalentLiofilchem, Inc.
FDA 510(k) clearance K261853 for Gepotidacin GEP 10 µg, Substantially Equivalent on 2026-07-23. Applicant: Liofilchem, Inc.. Device class: 2.
Summary
Liofilchem's Gepotidacin GEP 10 µg is filed under JTN, antimicrobial susceptibility test discs. The record gives no details beyond the name and code.
Class II, 21 CFR 866.1620. Microbiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Liofilchem filed from Waltham, Massachusetts. Review took 50 calendar days (June 3 to July 23, 2026).
Clearance details
- Applicant
- Liofilchem, Inc.
- Product code
- Product code JTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
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