ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET— 510(k) K131244

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K131244 for ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET, Substantially Equivalent on 2014-01-27. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 2013-05-01
Decision date: 2014-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.