K192547

Substantially Equivalent

MAGLUMI 2000 HCG/ß-HCG

Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Product code: DHA
Advisory panel: Clinical Chemistry
Date received: 2019-09-17
Decision date: 2020-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.