COAG-A-MATE MTX III— 510(k) K051030

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K051030 for COAG-A-MATE MTX III, Substantially Equivalent on 2005-12-23. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 2005-04-22
Decision date: 2005-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.