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FDA 510(k)

HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)

K-Number: K172621 · 2017-10-03

ApplicantHardy Diagnostics
Decision Date2017-10-03
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2017-10-03 under approval number K172621. 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 Meropenem/Vaborbactam 20/10µg (MEV30)?

HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) is a medical device that received FDA 510(k) clearance on 2017-10-03. It is manufactured by Hardy Diagnostics. The 510(k) number is K172621.

When was HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) approved by the FDA?

HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) received FDA 510(k) clearance on 2017-10-03, under approval number K172621.

What company makes HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)?

HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) is manufactured by Hardy Diagnostics.

What is the FDA product code for HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)?

The FDA product code for HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) is JTN.

Other Devices by Hardy Diagnostics

K160512HardyCHROM ESBL 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 K182357HardyDisk AST Eravacycline 20µg (ERV20)

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Related Devices (Code: JTN)

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 K192326HardyDisk AST Lefamulin 20µg (LMU20)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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