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FDA 510(k)

PYLORI IGG

K-Number: K033067 · 2003-11-26

ApplicantTrinity Biotech USA
Decision Date2003-11-26
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYLORI IGG is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Biotech USA. It received FDA 510(k) clearance on 2003-11-26 under 510(k) number K033067. 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 PYLORI IGG?

PYLORI IGG is a medical device that received FDA 510(k) clearance on 2003-11-26. The listed applicant is Trinity Biotech USA. The 510(k) number is K033067.

When did PYLORI IGG receive FDA 510(k) clearance?

PYLORI IGG received FDA 510(k) clearance on 2003-11-26, under 510(k) number K033067.

Who is the listed applicant for PYLORI IGG?

The FDA 510(k) record lists Trinity Biotech USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PYLORI IGG?

The FDA product code for PYLORI IGG is 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.

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