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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
Recalls CDRH Recalls
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