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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K932747
Device Name CIBA CORNING ACS FREE T3 IMMUNOASSAY
Applicant
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE,  MA  02032
Applicant Contact William J Pignato
Correspondent
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE,  MA  02032
Correspondent Contact William J Pignato
Regulation Number862.1710
Classification Product Code
CDP  
Subsequent Product Code
JIS  
Date Received06/08/1993
Decision Date 12/03/1993
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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