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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 K962602
Device Name ACA PLUS FREE THYROXINE(FT4) METHOD
Applicant
Dade Intl., Inc.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714
Applicant Contact CATHY P CRAFT
Correspondent
Dade Intl., Inc.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact CATHY P CRAFT
Regulation Number862.1695
Classification Product Code
CEC  
Date Received07/02/1996
Decision Date 08/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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