Cleared Traditional

Ceftobiprole BPR 5 ?g Disc

K250885 · Liofilchem, Inc. · Microbiology

Jun 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K250885 is an FDA 510(k) clearance for the Ceftobiprole BPR 5 ?g Disc, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Liofilchem, Inc. (Waltham, US). The FDA issued a Cleared decision on June 23, 2025, 90 days after receiving the submission on March 25, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number	K250885 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2025
Decision Date	June 23, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement