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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K070708
Device Name OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104
Applicant
OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
LISMEEHAN, O'CALLAGHANS MILLS
CO. CLARE,  IE
Applicant Contact STEPHANIE G SCHWARTZ
Correspondent
OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
LISMEEHAN, O'CALLAGHANS MILLS
CO. CLARE,  IE
Correspondent Contact STEPHANIE G SCHWARTZ
Regulation Number862.1695
Classification Product Code
CEC  
Subsequent Product Code
CDX  
Date Received03/14/2007
Decision Date 08/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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