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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
510(k) Number K902861
Device Name CIBA CORNING ACS DIGOXIN IMMUNOASSAY
Applicant
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Applicant Contact William J Pignato
Correspondent
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Correspondent Contact William J Pignato
Regulation Number862.3320
Classification Product Code
DON  
Date Received06/28/1990
Decision Date 09/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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