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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrolyte Controls (Assayed And Unassayed)
510(k) Number K894576
Device Name CIBA CORNING CERTAIN LYTE
Applicant
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Applicant Contact William Pignato
Correspondent
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Correspondent Contact William Pignato
Regulation Number862.1660
Classification Product Code
JJR  
Date Received07/21/1989
Decision Date 10/30/1989
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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