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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 K892205
Device Name DANAM VECTOR-8+
Applicant
Danam Electronics
4230 Shilling Way
Dallas,  TX  75237
Applicant Contact JERRY B WEST
Correspondent
Danam Electronics
4230 Shilling Way
Dallas,  TX  75237
Correspondent Contact JERRY B WEST
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received04/03/1989
Decision Date 06/13/1989
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
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