Sulopenem SPM 2 µg— 510(k) K251879

Substantially Equivalent

Liofilchem

FDA 510(k) clearance K251879 for Sulopenem SPM 2 µg, Substantially Equivalent on 2025-08-12. Applicant: Liofilchem.

Clearance details

Applicant: Liofilchem
Product code: Code JTN
Advisory panel: Microbiology
Date received: 2025-06-18
Decision date: 2025-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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