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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K911984
Device Name ANEMIA I, II
Applicant
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE,  MA  02032
Applicant Contact SANDRA A MANN
Correspondent
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE,  MA  02032
Correspondent Contact SANDRA A MANN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/03/1991
Decision Date 06/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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