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FDA 510(k)

Ceftobiprole BPR 5 µg Disc

K-Number: K250885 · 2025-06-23

ApplicantLiofilchem, Inc.
Decision Date2025-06-23
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Ceftobiprole BPR 5 µg Disc is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem, Inc.. It received FDA 510(k) clearance on 2025-06-23 under 510(k) number K250885. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceftobiprole BPR 5 µg Disc?

Ceftobiprole BPR 5 µg Disc is a medical device that received FDA 510(k) clearance on 2025-06-23. The listed applicant is Liofilchem, Inc.. The 510(k) number is K250885.

When did Ceftobiprole BPR 5 µg Disc receive FDA 510(k) clearance?

Ceftobiprole BPR 5 µg Disc received FDA 510(k) clearance on 2025-06-23, under 510(k) number K250885.

Who is the listed applicant for Ceftobiprole BPR 5 µg Disc?

The FDA 510(k) record lists Liofilchem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ceftobiprole BPR 5 µg Disc?

The FDA product code for Ceftobiprole BPR 5 µg Disc is JTN.

Other records listing Liofilchem, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261853Gepotidacin GEP 10 µgK251879Sulopenem SPM 2 µg

Related Devices (Code: JTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy DiagnosticsK251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy DiagnosticsK251879Sulopenem SPM 2 µgLiofilchem

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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