FDA 510(k)

H. PYLORI CHEK

K-Number: K181400 · 2018-08-21

Decision Date2018-08-21

Product CodeLYR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

H. PYLORI CHEK is a medical device manufactured by Techlab, Inc.. It received FDA 510(k) clearance on 2018-08-21 under approval number K181400. 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 H. PYLORI CHEK?

H. PYLORI CHEK is a medical device that received FDA 510(k) clearance on 2018-08-21. It is manufactured by Techlab, Inc.. The 510(k) number is K181400.

When was H. PYLORI CHEK approved by the FDA?

H. PYLORI CHEK received FDA 510(k) clearance on 2018-08-21, under approval number K181400.

What company makes H. PYLORI CHEK?

H. PYLORI CHEK is manufactured by Techlab, Inc..

What is the FDA product code for H. PYLORI CHEK?

The FDA product code for H. PYLORI CHEK is LYR.

Other Devices by Techlab, Inc.

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Related Devices (Code: LYR)

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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.