Olympus FT4-FREE Thyroxine, Olympus T4- Total Thyroxine, Model# OSR210102, OSR210104

FDA 510(k) K070708 · Olympus Life & Material Science Europa GmbH (Irish

Substantially Equivalent

510(k) numberK070708

Submission

Device name
Olympus FT4-FREE Thyroxine, Olympus T4- Total Thyroxine, Model# OSR210102, OSR210104
Applicant
Olympus Life & Material Science Europa GmbH (Irish
Co. Clare, IE
Received
March 14, 2007
Decision date
August 21, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CEC – Radioimmunoassay, Free Thyroxine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1695
Specialty
Clinical Chemistry

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Questions and answers

When was Olympus FT4-FREE Thyroxine, Olympus T4- Total Thyroxine, Model# OSR210102, OSR210104 cleared by the FDA?

Olympus FT4-FREE Thyroxine, Olympus T4- Total Thyroxine, Model# OSR210102, OSR210104 (K070708) received a 510(k) decision of Substantially Equivalent on August 21, 2007, 160 days after the submission was received.

What is the product code of K070708?

The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.