MAGLUMI 2000 FT4— 510(k) K182423
Substantially EquivalentShenzhen New Industries Biomedical Engineering Co., Ltd.
FDA 510(k) clearance K182423 for MAGLUMI 2000 FT4, Substantially Equivalent on 2018-10-04. Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd..
Clearance details
- Applicant
- Shenzhen New Industries Biomedical Engineering Co., Ltd.
- Product code
- Code CEC
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- 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, through . 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.