HardyDisk AST Plazomicin 30ug (PLZ30)
K-Number: K181700 · 2018-07-10
ApplicantHardy Diagnostics
Decision Date2018-07-10
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
HardyDisk AST Plazomicin 30ug (PLZ30) is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2018-07-10 under approval number K181700. 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 Plazomicin 30ug (PLZ30)?
HardyDisk AST Plazomicin 30ug (PLZ30) is a medical device that received FDA 510(k) clearance on 2018-07-10. It is manufactured by Hardy Diagnostics. The 510(k) number is K181700.
When was HardyDisk AST Plazomicin 30ug (PLZ30) approved by the FDA?
HardyDisk AST Plazomicin 30ug (PLZ30) received FDA 510(k) clearance on 2018-07-10, under approval number K181700.
What company makes HardyDisk AST Plazomicin 30ug (PLZ30)?
HardyDisk AST Plazomicin 30ug (PLZ30) is manufactured by Hardy Diagnostics.
What is the FDA product code for HardyDisk AST Plazomicin 30ug (PLZ30)?
The FDA product code for HardyDisk AST Plazomicin 30ug (PLZ30) 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.