K182423

Substantially Equivalent

MAGLUMI 2000 FT4

Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Product code: CEC
Advisory panel: Clinical Chemistry
Date received: 2018-09-06
Decision date: 2018-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.