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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 K874875
Device Name CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)
Applicant
Boots-Celltech Diagnostics, Inc.
1 S. Ridgedale Ave.
East Hanover,  NJ  07936
Applicant Contact JOHN SIMPSON
Correspondent
Boots-Celltech Diagnostics, Inc.
1 S. Ridgedale Ave.
East Hanover,  NJ  07936
Correspondent Contact JOHN SIMPSON
Regulation Number862.1695
Classification Product Code
CEC  
Date Received11/27/1987
Decision Date 03/24/1988
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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