FDA 510(k)

MagXtract Collection Tube

K-Number: K212113 · 2022-07-28

Decision Date2022-07-28

Product CodeQBD

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MagXtract Collection Tube is a medical device manufactured by Magbio Genomics, Inc.. It received FDA 510(k) clearance on 2022-07-28 under approval number K212113. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MagXtract Collection Tube?

MagXtract Collection Tube is a medical device that received FDA 510(k) clearance on 2022-07-28. It is manufactured by Magbio Genomics, Inc.. The 510(k) number is K212113.

When was MagXtract Collection Tube approved by the FDA?

MagXtract Collection Tube received FDA 510(k) clearance on 2022-07-28, under approval number K212113.

What company makes MagXtract Collection Tube?

MagXtract Collection Tube is manufactured by Magbio Genomics, Inc..

What is the FDA product code for MagXtract Collection Tube?

The FDA product code for MagXtract Collection Tube is QBD.

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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.