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FDA 510(k)

HELICOBACTER PYLORI ELISA IGG TEST KIT

K-Number: K110745 · 2012-03-02

ApplicantGold Standard Diagnostics
Decision Date2012-03-02
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HELICOBACTER PYLORI ELISA IGG TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Gold Standard Diagnostics. It received FDA 510(k) clearance on 2012-03-02 under 510(k) number K110745. 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 HELICOBACTER PYLORI ELISA IGG TEST KIT?

HELICOBACTER PYLORI ELISA IGG TEST KIT is a medical device that received FDA 510(k) clearance on 2012-03-02. The listed applicant is Gold Standard Diagnostics. The 510(k) number is K110745.

When did HELICOBACTER PYLORI ELISA IGG TEST KIT receive FDA 510(k) clearance?

HELICOBACTER PYLORI ELISA IGG TEST KIT received FDA 510(k) clearance on 2012-03-02, under 510(k) number K110745.

Who is the listed applicant for HELICOBACTER PYLORI ELISA IGG TEST KIT?

The FDA 510(k) record lists Gold Standard Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HELICOBACTER PYLORI ELISA IGG TEST KIT?

The FDA product code for HELICOBACTER PYLORI ELISA IGG TEST KIT is LYR.

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Other records listing Gold Standard Diagnostics as applicant

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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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