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FDA 510(k)

H. PYLORI CHEK™

K-Number: K181400 · 2018-08-21

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

Device Summary

H. PYLORI 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 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. The listed applicant is Techlab, Inc.. The 510(k) number is K181400.

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

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

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

The FDA product code for H. PYLORI 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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Related Devices (Code: LYR)

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.

K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.

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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