IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4— 510(k) K160647

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K160647 for IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4, Substantially Equivalent on 2016-05-31. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2016-03-07
Decision date: 2016-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, 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.