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FDA 510(k)

COAG-A-MATE MTX III

K-Number: K051030 · 2005-12-23

ApplicantbioMerieux, Inc.
Decision Date2005-12-23
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAG-A-MATE MTX III is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2005-12-23 under 510(k) number K051030. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAG-A-MATE MTX III?

COAG-A-MATE MTX III is a medical device that received FDA 510(k) clearance on 2005-12-23. The listed applicant is bioMerieux, Inc.. The 510(k) number is K051030.

When did COAG-A-MATE MTX III receive FDA 510(k) clearance?

COAG-A-MATE MTX III received FDA 510(k) clearance on 2005-12-23, under 510(k) number K051030.

Who is the listed applicant for COAG-A-MATE MTX III?

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

What is the FDA product code for COAG-A-MATE MTX III?

The FDA product code for COAG-A-MATE MTX III is JPA.

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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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