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FDA 510(k)

MACRA LP(A) ENZYME IMMUNOASSAY KIT

K-Number: K992665 · 1999-11-26

ApplicantTrinity Biotech USA
Decision Date1999-11-26
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MACRA LP(A) ENZYME IMMUNOASSAY KIT 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 1999-11-26 under 510(k) number K992665. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACRA LP(A) ENZYME IMMUNOASSAY KIT?

MACRA LP(A) ENZYME IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is Trinity Biotech USA. The 510(k) number is K992665.

When did MACRA LP(A) ENZYME IMMUNOASSAY KIT receive FDA 510(k) clearance?

MACRA LP(A) ENZYME IMMUNOASSAY KIT received FDA 510(k) clearance on 1999-11-26, under 510(k) number K992665.

Who is the listed applicant for MACRA LP(A) ENZYME IMMUNOASSAY KIT?

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 MACRA LP(A) ENZYME IMMUNOASSAY KIT?

The FDA product code for MACRA LP(A) ENZYME IMMUNOASSAY KIT is DFC.

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Related Devices (Code: DFC)

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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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