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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 K896222
Device Name FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT
Applicant
Nichols Institute Diagnostics
P.O. Box 92797
Los Angeles,  CA  90009
Applicant Contact SANDRA MORRIS
Correspondent
Nichols Institute Diagnostics
P.O. Box 92797
Los Angeles,  CA  90009
Correspondent Contact SANDRA MORRIS
Regulation Number862.1695
Classification Product Code
CEC  
Date Received10/30/1989
Decision Date 11/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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