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FDA 510(k)

MYCOPLASMA IGG

K-Number: K033064 · 2003-11-26

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

Device Summary

MYCOPLASMA 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 K033064. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYCOPLASMA IGG?

MYCOPLASMA 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 K033064.

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

MYCOPLASMA IGG received FDA 510(k) clearance on 2003-11-26, under 510(k) number K033064.

Who is the listed applicant for MYCOPLASMA 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 MYCOPLASMA IGG?

The FDA product code for MYCOPLASMA IGG is LON.

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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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