Ceftobiprole BPR 5 µg Disc— 510(k) K250885

Substantially Equivalent

Liofilchem, Inc.

FDA 510(k) clearance K250885 for Ceftobiprole BPR 5 µg Disc, Substantially Equivalent on 2025-06-23. Applicant: Liofilchem, Inc..

Clearance details

Applicant: Liofilchem, Inc.
Product code: Code JTN
Advisory panel: Microbiology
Date received: 2025-03-25
Decision date: 2025-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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