OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104— 510(k) K070708

Name: FDA 510(k) clearance K070708
Creator: U.S. Food and Drug Administration
Published: 2007-08-21

Substantially Equivalent

Olympus Life & Material Science Europa GmbH (Irish

FDA 510(k) clearance K070708 for OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104, Substantially Equivalent on 2007-08-21. Applicant: Olympus Life & Material Science Europa GmbH (Irish. Device class: 2.

Clearance details

Applicant: Olympus Life & Material Science Europa GmbH (Irish
Product code: Code CEC
Device class: Class 2
Regulation: 21 CFR 862.1695
Advisory panel: Clinical Chemistry
Date received: 2007-03-14
Decision date: 2007-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Co. Clare, IE

Download summary PDF View on FDA.gov ↗

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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.