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510(k) K070708

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 by Olympus Life & Material Science Europa GmbH (Irish — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2007
Date Received
March 14, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Free Thyroxine
Device Class
Class II
Regulation Number
862.1695
Review Panel
CH
Submission Type

Other clearances by Olympus Life & Material Science Europa GmbH (Irish

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