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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 K870268
Device Name DIAGNOSTIC KIT FREE T3 AND FREE T4
Applicant
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Applicant Contact KING, PH.D.
Correspondent
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Correspondent Contact KING, PH.D.
Regulation Number862.1695
Classification Product Code
CEC  
Date Received01/23/1987
Decision Date 09/14/1987
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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