HardyDisk AST Omadacycline 30µg (OMC30)
K-Number: K183298 · 2019-01-18
ApplicantHardy Diagnostics
Decision Date2019-01-18
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
HardyDisk AST Omadacycline 30µg (OMC30) is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2019-01-18 under approval number K183298. 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 Omadacycline 30µg (OMC30)?
HardyDisk AST Omadacycline 30µg (OMC30) is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by Hardy Diagnostics. The 510(k) number is K183298.
When was HardyDisk AST Omadacycline 30µg (OMC30) approved by the FDA?
HardyDisk AST Omadacycline 30µg (OMC30) received FDA 510(k) clearance on 2019-01-18, under approval number K183298.
What company makes HardyDisk AST Omadacycline 30µg (OMC30)?
HardyDisk AST Omadacycline 30µg (OMC30) is manufactured by Hardy Diagnostics.
What is the FDA product code for HardyDisk AST Omadacycline 30µg (OMC30)?
The FDA product code for HardyDisk AST Omadacycline 30µg (OMC30) is JTN.
Other Devices by Hardy Diagnostics
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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.