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FDA 510(k)

Sulopenem SPM 2 µg

K-Number: K251879 · 2025-08-12

ApplicantLiofilchem
Decision Date2025-08-12
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sulopenem SPM 2 µg is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K251879. 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 Sulopenem SPM 2 µg?

Sulopenem SPM 2 µg is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Liofilchem. The 510(k) number is K251879.

When did Sulopenem SPM 2 µg receive FDA 510(k) clearance?

Sulopenem SPM 2 µg received FDA 510(k) clearance on 2025-08-12, under 510(k) number K251879.

Who is the listed applicant for Sulopenem SPM 2 µg?

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

What is the FDA product code for Sulopenem SPM 2 µg?

The FDA product code for Sulopenem SPM 2 µg is JTN.

Other records listing Liofilchem 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 µgK250885Ceftobiprole BPR 5 µg Disc

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 DiagnosticsK250956HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics

Official Source

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