HardyDisk AST Lefamulin 20µg (LMU20)
K-Number: K192326 · 2019-09-19
ApplicantHardy Diagnostics
Decision Date2019-09-19
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
HardyDisk AST Lefamulin 20µg (LMU20) is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2019-09-19 under approval number K192326. 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 Lefamulin 20µg (LMU20)?
HardyDisk AST Lefamulin 20µg (LMU20) is a medical device that received FDA 510(k) clearance on 2019-09-19. It is manufactured by Hardy Diagnostics. The 510(k) number is K192326.
When was HardyDisk AST Lefamulin 20µg (LMU20) approved by the FDA?
HardyDisk AST Lefamulin 20µg (LMU20) received FDA 510(k) clearance on 2019-09-19, under approval number K192326.
What company makes HardyDisk AST Lefamulin 20µg (LMU20)?
HardyDisk AST Lefamulin 20µg (LMU20) is manufactured by Hardy Diagnostics.
What is the FDA product code for HardyDisk AST Lefamulin 20µg (LMU20)?
The FDA product code for HardyDisk AST Lefamulin 20µg (LMU20) is JTN.
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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.