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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K870233
Device Name CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
Applicant
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Applicant Contact RUTH M BECKER
Correspondent
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Correspondent Contact RUTH M BECKER
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received01/21/1987
Decision Date 03/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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