FDA 510(k)

Hp Detect Stool Antigen ELISA

K-Number: K232892 · 2023-12-15

Decision Date2023-12-15

Product CodeLYR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Hp Detect Stool Antigen ELISA is a medical device manufactured by Biomerica, Inc.. It received FDA 510(k) clearance on 2023-12-15 under approval number K232892. 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 Hp Detect Stool Antigen ELISA?

Hp Detect Stool Antigen ELISA is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Biomerica, Inc.. The 510(k) number is K232892.

When was Hp Detect Stool Antigen ELISA approved by the FDA?

Hp Detect Stool Antigen ELISA received FDA 510(k) clearance on 2023-12-15, under approval number K232892.

What company makes Hp Detect Stool Antigen ELISA?

Hp Detect Stool Antigen ELISA is manufactured by Biomerica, Inc..

What is the FDA product code for Hp Detect Stool Antigen ELISA?

The FDA product code for Hp Detect Stool Antigen ELISA is 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.