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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 K870158
Device Name STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.
Applicant
AMERICAN DADE
P.O. BOX 25101
SANTA ANA,  CA  92799
Applicant Contact KAREN H DARCY
Correspondent
AMERICAN DADE
P.O. BOX 25101
SANTA ANA,  CA  92799
Correspondent Contact KAREN H DARCY
Regulation Number862.1695
Classification Product Code
CEC  
Date Received01/13/1987
Decision Date 03/19/1987
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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