TETRACHROME REAGENTS AND TETRACXP SYSTEM— 510(k) K121445

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K121445 for TETRACHROME REAGENTS AND TETRACXP SYSTEM, Substantially Equivalent on 2013-07-26. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code OYE
Advisory panel: Hematology
Date received: 2012-05-15
Decision date: 2013-07-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

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Adverse events under product code OYE

product code OYE

Malfunction: 828
Total: 828

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.