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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 K931110
Device Name RADIAS FREE T4 ENZYME IMMUNOASSAY
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact TREVOR WALL
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact TREVOR WALL
Regulation Number862.1695
Classification Product Code
CEC  
Date Received03/03/1993
Decision Date 05/20/1993
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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