FDA 510(k)

HardyDisk AST Cefiderocol 30µg (FDC30)

K-Number: K253105 · 2025-11-20

Decision Date2025-11-20

Product CodeJTN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

HardyDisk AST Cefiderocol 30µg (FDC30) is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K253105. 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 HardyDisk AST Cefiderocol 30µg (FDC30)?

HardyDisk AST Cefiderocol 30µg (FDC30) is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Hardy Diagnostics. The 510(k) number is K253105.

When did HardyDisk AST Cefiderocol 30µg (FDC30) receive FDA 510(k) clearance?

HardyDisk AST Cefiderocol 30µg (FDC30) received FDA 510(k) clearance on 2025-11-20, under 510(k) number K253105.

Who is the listed applicant for HardyDisk AST Cefiderocol 30µg (FDC30)?

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

What is the FDA product code for HardyDisk AST Cefiderocol 30µg (FDC30)?

The FDA product code for HardyDisk AST Cefiderocol 30µg (FDC30) is JTN.

Other records listing Hardy Diagnostics 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.

K260842HardyDisk AST Gepotidacin 10µg (GEP10)K250956HardyDisk AST Gepotidacin 10µg (GEP10)K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)K233534Viral Transport Medium K241060HardyDisk AST Cefiderocol 30µg (FDC30)K231568HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)

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Related Devices (Code: JTN)

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 Diagnostics K251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K251879Sulopenem SPM 2 µgLiofilchem K250956HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics

Official Source

View on FDA Database →

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