MaxiGen
K-Number: K152077 · 2016-04-21
ApplicantHans Biomed Corp.
Decision Date2016-04-21
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MaxiGen is a medical device manufactured by Hans Biomed Corp.. It received FDA 510(k) clearance on 2016-04-21 under approval number K152077. 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 MaxiGen?
MaxiGen is a medical device that received FDA 510(k) clearance on 2016-04-21. It is manufactured by Hans Biomed Corp.. The 510(k) number is K152077.
When was MaxiGen approved by the FDA?
MaxiGen received FDA 510(k) clearance on 2016-04-21, under approval number K152077.
What company makes MaxiGen?
MaxiGen is manufactured by Hans Biomed Corp..
What is the FDA product code for MaxiGen?
The FDA product code for MaxiGen is MQV.
Other Devices by Hans Biomed Corp.
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.