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FDA 510(k)

H. PYLORI QUIK CHEK

K-Number: K181379 · 2018-08-21

ApplicantTechlab, Inc.
Decision Date2018-08-21
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

H. PYLORI QUIK CHEK is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2018-08-21 under 510(k) 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. The listed applicant is Techlab, Inc.. The 510(k) number is K181379.

When did H. PYLORI QUIK CHEK receive FDA 510(k) clearance?

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

Who is the listed applicant for H. PYLORI QUIK CHEK?

The FDA 510(k) record lists Techlab, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Techlab, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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