Agilon Strip
K-Number: K193487 · 2020-03-30
ApplicantBiogennix, LLC
Decision Date2020-03-30
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Agilon Strip is a medical device manufactured by Biogennix, LLC. It received FDA 510(k) clearance on 2020-03-30 under approval number K193487. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Agilon Strip?
Agilon Strip is a medical device that received FDA 510(k) clearance on 2020-03-30. It is manufactured by Biogennix, LLC. The 510(k) number is K193487.
When was Agilon Strip approved by the FDA?
Agilon Strip received FDA 510(k) clearance on 2020-03-30, under approval number K193487.
What company makes Agilon Strip?
Agilon Strip is manufactured by Biogennix, LLC.
What is the FDA product code for Agilon Strip?
The FDA product code for Agilon Strip is MQV.
Other Devices by Biogennix, LLC
Related Devices (Code: MQV)
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.