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FDA 510(k)

HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40

K-Number: K170127 · 2017-03-14

ApplicantHardy Diagnostics
Decision Date2017-03-14
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2017-03-14 under approval number K170127. 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 Ceftolozane/Tazobactam, (30/10 ug)-C/T40?

HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 is a medical device that received FDA 510(k) clearance on 2017-03-14. It is manufactured by Hardy Diagnostics. The 510(k) number is K170127.

When was HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 approved by the FDA?

HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 received FDA 510(k) clearance on 2017-03-14, under approval number K170127.

What company makes HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40?

HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 is manufactured by Hardy Diagnostics.

What is the FDA product code for HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40?

The FDA product code for HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 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 K182357HardyDisk AST Eravacycline 20µg (ERV20)

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Related Devices (Code: JTN)

K172621HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)Hardy Diagnostics K171975HardyDisk AST Delafloxacin 5 µg (DLX5)Hardy 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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