FDA 510(k)

H. PYLORI QUIK CHEK

K-Number: K181379 · 2018-08-21

Decision Date2018-08-21

Product CodeLYR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

H. PYLORI QUIK CHEK is a medical device manufactured by Techlab, Inc.. It received FDA 510(k) clearance on 2018-08-21 under approval number K181379. 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 QUIK CHEK?

H. PYLORI QUIK 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 K181379.

When was H. PYLORI QUIK CHEK approved by the FDA?

H. PYLORI QUIK CHEK received FDA 510(k) clearance on 2018-08-21, under approval number K181379.

What company makes H. PYLORI QUIK CHEK?

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

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

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

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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.