K160541

Substantially Equivalent

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control

Applicant: Sysmex America, Inc.
Product code: JLW
Advisory panel: Clinical Chemistry
Date received: 2016-02-26
Decision date: 2016-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincolnshire, IL, US

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.