MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer— 510(k) K162698

Substantially Equivalent

Shenzhen New Industries Biomedical Engineering Co., Ltd.

FDA 510(k) clearance K162698 for MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer, Substantially Equivalent on 2017-07-14. Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd..

Clearance details

Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2016-09-27
Decision date: 2017-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.