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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 COURT
WAYNE,  NJ  07470
Applicant Contact KING, PH.D.
Correspondent
SCLAVO, INC.
5 MANSARD COURT
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
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