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FDA 510(k)

MaxiGen

K-Number: K152077 · 2016-04-21

ApplicantHans Biomed Corp.
Decision Date2016-04-21
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MaxiGen is the device name listed in this FDA 510(k) record. The listed applicant is Hans Biomed Corp.. It received FDA 510(k) clearance on 2016-04-21 under 510(k) 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. The listed applicant is Hans Biomed Corp.. The 510(k) number is K152077.

When did MaxiGen receive FDA 510(k) clearance?

MaxiGen received FDA 510(k) clearance on 2016-04-21, under 510(k) number K152077.

Who is the listed applicant for MaxiGen?

The FDA 510(k) record lists Hans Biomed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MaxiGen?

The FDA product code for MaxiGen is MQV.

Other records listing Hans Biomed Corp. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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