LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3— 510(k) K130469

Substantially Equivalent

DiaSorin, Inc.

FDA 510(k) clearance K130469 for LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3, Substantially Equivalent on 2013-04-05. Applicant: DiaSorin, Inc..

Clearance details

Applicant: DiaSorin, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2013-02-25
Decision date: 2013-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

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.