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FDA 510(k)

LEGIONELLA PNEUMOPHILA IGG/IGM

K-Number: K033051 · 2003-11-26

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

Device Summary

LEGIONELLA PNEUMOPHILA IGG/IGM 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 K033051. The device is classified under product code MJH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGIONELLA PNEUMOPHILA IGG/IGM?

LEGIONELLA PNEUMOPHILA IGG/IGM 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 K033051.

When did LEGIONELLA PNEUMOPHILA IGG/IGM receive FDA 510(k) clearance?

LEGIONELLA PNEUMOPHILA IGG/IGM received FDA 510(k) clearance on 2003-11-26, under 510(k) number K033051.

Who is the listed applicant for LEGIONELLA PNEUMOPHILA IGG/IGM?

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 LEGIONELLA PNEUMOPHILA IGG/IGM?

The FDA product code for LEGIONELLA PNEUMOPHILA IGG/IGM is MJH.

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Related Devices (Code: MJH)

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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