MAGLUMI 2000 HCG/ß-HCG— 510(k) K192547

Substantially Equivalent

Shenzhen New Industries Biomedical Engineering Co., Ltd.

FDA 510(k) clearance K192547 for MAGLUMI 2000 HCG/ß-HCG, Substantially Equivalent on 2020-01-17. Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd..

Clearance details

Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.