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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Thyroxine
510(k) Number K860421
Device Name STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
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 Number862.1700
Classification Product Code
CDX  
Date Received02/04/1986
Decision Date 02/11/1986
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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