K232791

Substantially Equivalent

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Applicant: Beckman Coulter, Inc.
Product code: CEW
Advisory panel: Clinical Chemistry
Date received: 2023-09-11
Decision date: 2024-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

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.