TruDiagnosis System
K-Number: K183530 · 2019-05-24
ApplicantAkonni Biosystems, Inc.
Decision Date2019-05-24
Product CodeODW
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
TruDiagnosis System is a medical device manufactured by Akonni Biosystems, Inc.. It received FDA 510(k) clearance on 2019-05-24 under approval number K183530. The device is classified under product code ODW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TruDiagnosis System?
TruDiagnosis System is a medical device that received FDA 510(k) clearance on 2019-05-24. It is manufactured by Akonni Biosystems, Inc.. The 510(k) number is K183530.
When was TruDiagnosis System approved by the FDA?
TruDiagnosis System received FDA 510(k) clearance on 2019-05-24, under approval number K183530.
What company makes TruDiagnosis System?
TruDiagnosis System is manufactured by Akonni Biosystems, Inc..
What is the FDA product code for TruDiagnosis System?
The FDA product code for TruDiagnosis System is ODW.
Related Devices (Code: ODW)
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.