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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Triiodothyronine Uptake
510(k) Number K902748
Device Name SEROZYME FREE T3 IMMUNOASSAY
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 Number862.1715
Classification Product Code
KHQ  
Date Received06/22/1990
Decision Date 08/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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