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FDA 510(k)

ENA PROFILE ELISA TEST SYSTEM

K-Number: K993839 · 2000-01-12

ApplicantTrinity Biotech USA
Decision Date2000-01-12
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENA PROFILE 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 2000-01-12 under 510(k) number K993839. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENA PROFILE ELISA TEST SYSTEM?

ENA PROFILE ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2000-01-12. The listed applicant is Trinity Biotech USA. The 510(k) number is K993839.

When did ENA PROFILE ELISA TEST SYSTEM receive FDA 510(k) clearance?

ENA PROFILE ELISA TEST SYSTEM received FDA 510(k) clearance on 2000-01-12, under 510(k) number K993839.

Who is the listed applicant for ENA PROFILE 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 ENA PROFILE ELISA TEST SYSTEM?

The FDA product code for ENA PROFILE ELISA TEST SYSTEM is LLL.

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Related Devices (Code: LLL)

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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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