FDA 510(k)

Vstrip H. pylori Antigen Rapid Test

K-Number: K183573 · 2019-03-14

Decision Date2019-03-14

Product CodeLYR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Vstrip H. pylori Antigen Rapid Test is a medical device manufactured by Panion & BF Biotech, Inc.. It received FDA 510(k) clearance on 2019-03-14 under approval number K183573. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vstrip H. pylori Antigen Rapid Test?

Vstrip H. pylori Antigen Rapid Test is a medical device that received FDA 510(k) clearance on 2019-03-14. It is manufactured by Panion & BF Biotech, Inc.. The 510(k) number is K183573.

When was Vstrip H. pylori Antigen Rapid Test approved by the FDA?

Vstrip H. pylori Antigen Rapid Test received FDA 510(k) clearance on 2019-03-14, under approval number K183573.

What company makes Vstrip H. pylori Antigen Rapid Test?

Vstrip H. pylori Antigen Rapid Test is manufactured by Panion & BF Biotech, Inc..

What is the FDA product code for Vstrip H. pylori Antigen Rapid Test?

The FDA product code for Vstrip H. pylori Antigen Rapid Test is LYR.

Related Devices (Code: LYR)

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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.