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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 K884753
Device Name MODIFIED FREE T4 RADIOIMMUNOASSAY KIT
Applicant
Advanced Magnetics, Inc.
61 Mooney St.
Cambridge,  MA  02138
Applicant Contact MARK C ROESSEL
Correspondent
Advanced Magnetics, Inc.
61 Mooney St.
Cambridge,  MA  02138
Correspondent Contact MARK C ROESSEL
Regulation Number862.1695
Classification Product Code
CEC  
Date Received11/14/1988
Decision Date 02/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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