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FDA 510(k)

CHLAMYDIA IGG ELISA TEST SYSTEM

K-Number: K033079 · 2003-11-26

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

Device Summary

CHLAMYDIA IGG 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 K033079. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLAMYDIA IGG ELISA TEST SYSTEM?

CHLAMYDIA IGG 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 K033079.

When did CHLAMYDIA IGG ELISA TEST SYSTEM receive FDA 510(k) clearance?

CHLAMYDIA IGG ELISA TEST SYSTEM received FDA 510(k) clearance on 2003-11-26, under 510(k) number K033079.

Who is the listed applicant for CHLAMYDIA IGG 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 CHLAMYDIA IGG ELISA TEST SYSTEM?

The FDA product code for CHLAMYDIA IGG ELISA TEST SYSTEM is LJC.

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Other records listing Trinity Biotech USA as applicant

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Related Devices (Code: LJC)

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.

K032330CT OIAThermo Biostar, Inc.K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.K982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLCK960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, Inc.K955627VIDAS CHLAMYDIA BLOCKING ASSAYBiomerieux Vitek, Inc.

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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