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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
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