510(k) K250885

Ceftobiprole BPR 5 µg Disc by Liofilchem, Inc. — Product Code JTN

K250885 is an FDA 510(k) premarket notification submitted by Liofilchem, Inc. for the device "Ceftobiprole BPR 5 µg Disc". The FDA issued a decision of Substantially Equivalent on June 23, 2025. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Liofilchem, Inc. has at least 10 other 510(k) clearances on record.