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FDA 510(k)

CAPTIAM SYPHILIS-G ASSAY

K-Number: K014233 · 2002-01-24

ApplicantTrinity Biotech, Plc
Decision Date2002-01-24
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CAPTIAM SYPHILIS-G ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Biotech, Plc. It received FDA 510(k) clearance on 2002-01-24 under 510(k) number K014233. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPTIAM SYPHILIS-G ASSAY?

CAPTIAM SYPHILIS-G ASSAY is a medical device that received FDA 510(k) clearance on 2002-01-24. The listed applicant is Trinity Biotech, Plc. The 510(k) number is K014233.

When did CAPTIAM SYPHILIS-G ASSAY receive FDA 510(k) clearance?

CAPTIAM SYPHILIS-G ASSAY received FDA 510(k) clearance on 2002-01-24, under 510(k) number K014233.

Who is the listed applicant for CAPTIAM SYPHILIS-G ASSAY?

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

What is the FDA product code for CAPTIAM SYPHILIS-G ASSAY?

The FDA product code for CAPTIAM SYPHILIS-G ASSAY is LIP.

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Other records listing Trinity Biotech, Plc as applicant

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Related Devices (Code: LIP)

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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