HardyDisk AST Delafloxacin 5 µg (DLX5)
K-Number: K171975 · 2017-08-01
ApplicantHardy Diagnostics
Decision Date2017-08-01
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
HardyDisk AST Delafloxacin 5 µg (DLX5) is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2017-08-01 under approval number K171975. 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 Delafloxacin 5 µg (DLX5)?
HardyDisk AST Delafloxacin 5 µg (DLX5) is a medical device that received FDA 510(k) clearance on 2017-08-01. It is manufactured by Hardy Diagnostics. The 510(k) number is K171975.
When was HardyDisk AST Delafloxacin 5 µg (DLX5) approved by the FDA?
HardyDisk AST Delafloxacin 5 µg (DLX5) received FDA 510(k) clearance on 2017-08-01, under approval number K171975.
What company makes HardyDisk AST Delafloxacin 5 µg (DLX5)?
HardyDisk AST Delafloxacin 5 µg (DLX5) is manufactured by Hardy Diagnostics.
What is the FDA product code for HardyDisk AST Delafloxacin 5 µg (DLX5)?
The FDA product code for HardyDisk AST Delafloxacin 5 µg (DLX5) is JTN.
Other Devices by Hardy Diagnostics
Related Devices (Code: JTN)
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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.