IntelliSep test
K-Number: K220991 · 2022-12-20
ApplicantCytovale, Inc.
Decision Date2022-12-20
Product CodeQUT
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
IntelliSep test is a medical device manufactured by Cytovale, Inc.. It received FDA 510(k) clearance on 2022-12-20 under approval number K220991. The device is classified under product code QUT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IntelliSep test?
IntelliSep test is a medical device that received FDA 510(k) clearance on 2022-12-20. It is manufactured by Cytovale, Inc.. The 510(k) number is K220991.
When was IntelliSep test approved by the FDA?
IntelliSep test received FDA 510(k) clearance on 2022-12-20, under approval number K220991.
What company makes IntelliSep test?
IntelliSep test is manufactured by Cytovale, Inc..
What is the FDA product code for IntelliSep test?
The FDA product code for IntelliSep test is QUT.
Other Devices by Cytovale, Inc.
Related Devices (Code: QUT)
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.