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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 K951496
Device Name CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
Applicant
Abbott Laboratories
1825 Walnut Hill Ln.
1920 & 1921 Hurd Dr.
Irvin,  TX  75038
Applicant Contact JANICE E BROWN
Correspondent
Abbott Laboratories
1825 Walnut Hill Ln.
1920 & 1921 Hurd Dr.
Irvin,  TX  75038
Correspondent Contact JANICE E BROWN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/13/1995
Decision Date 10/19/1995
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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