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FDA 510(k)

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

K-Number: K033083 · 2003-11-26

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

Device Summary

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM 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 K033083. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM?

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM 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 K033083.

When did BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM receive FDA 510(k) clearance?

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM received FDA 510(k) clearance on 2003-11-26, under 510(k) number K033083.

Who is the listed applicant for BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM?

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 BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM?

The FDA product code for BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM is LSR.

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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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