Elecsys FT4 IV— 510(k) K220456

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K220456 for Elecsys FT4 IV, Substantially Equivalent on 2023-04-07. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 2022-02-17
Decision date: 2023-04-07
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.