FDA 510(k)

HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)

K-Number: K191931 · 2019-07-31

Decision Date2019-07-31

Product CodeJTN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K191931. 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 Imipenem/relebactam 10/25µg (IMR10/25)?

HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Hardy Diagnostics. The 510(k) number is K191931.

When did HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) receive FDA 510(k) clearance?

HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) received FDA 510(k) clearance on 2019-07-31, under 510(k) number K191931.

Who is the listed applicant for HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)?

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 Imipenem/relebactam 10/25µg (IMR10/25)?

The FDA product code for HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) 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)K253105HardyDisk AST Cefiderocol 30µg (FDC30)K250956HardyDisk AST Gepotidacin 10µg (GEP10)K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)K233534Viral Transport Medium K241060HardyDisk AST Cefiderocol 30µg (FDC30)

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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.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics K251879Sulopenem SPM 2 µgLiofilchem

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.