Cleared Traditional

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104

K070708 · Olympus Life & Material Science Europa GmbH (Irish · Chemistry

Aug 2007

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K070708 is an FDA 510(k) clearance for the OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Olympus Life & Material Science Europa GmbH (Irish (Co. Clare, IE). The FDA issued a Cleared decision on August 21, 2007, 160 days after receiving the submission on March 14, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number	K070708 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2007
Decision Date	August 21, 2007
Days to Decision	160 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement