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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 K900060
Device Name FREE T4 IMMUNOASSAY 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 Received01/03/1990
Decision Date 03/29/1990
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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