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FDA 510(k)

HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)

K-Number: K231568 · 2023-07-06

ApplicantHardy Diagnostics
Decision Date2023-07-06
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2023-07-06 under approval number K231568. 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 Sulbactam/Durlobactam 10/10µg (SUD20)?

HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) is a medical device that received FDA 510(k) clearance on 2023-07-06. It is manufactured by Hardy Diagnostics. The 510(k) number is K231568.

When was HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) approved by the FDA?

HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) received FDA 510(k) clearance on 2023-07-06, under approval number K231568.

What company makes HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)?

HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) is manufactured by Hardy Diagnostics.

What is the FDA product code for HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)?

The FDA product code for HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) 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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