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FDA 510(k)

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

K-Number: K191931 · 2019-07-31

ApplicantHardy Diagnostics
Decision Date2019-07-31
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2019-07-31 under approval 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. It is manufactured by Hardy Diagnostics. The 510(k) number is K191931.

When was HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) approved by the FDA?

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

What company makes HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)?

HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) is manufactured by Hardy Diagnostics.

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 Devices by Hardy Diagnostics

K160512HardyCHROM ESBL K172621HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) K171975HardyDisk AST Delafloxacin 5 µg (DLX5) K170586Strep B Carrot Broth One-Step K170481Strep B Carrot Broth Kit K170127HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40

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Related Devices (Code: JTN)

K172621HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)Hardy Diagnostics K171975HardyDisk AST Delafloxacin 5 µg (DLX5)Hardy Diagnostics K170127HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40Hardy Diagnostics K181975Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30Oxoid Limited (Part of Thermo Fisher Scientific) K182357HardyDisk AST Eravacycline 20µg (ERV20)Hardy Diagnostics K181700HardyDisk AST Plazomicin 30ug (PLZ30)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.

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