Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control— 510(k) K160541

Substantially Equivalent

Sysmex America, Inc.

FDA 510(k) clearance K160541 for Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control, Substantially Equivalent on 2016-10-21. Applicant: Sysmex America, Inc..

Clearance details

Applicant: Sysmex America, Inc.
Product code: 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

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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.