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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Cell Counter, Normal And Abnormal
510(k) Number K902391
Device Name CELL-DYN 3000 CONTROL
Applicant
Unipath , Ltd.
850 Maude Ave.
Mountain View,  CA  94043
Applicant Contact ANDREA HERRMANN
Correspondent
Unipath , Ltd.
850 Maude Ave.
Mountain View,  CA  94043
Correspondent Contact ANDREA HERRMANN
Regulation Number864.8625
Classification Product Code
JCN  
Date Received05/30/1990
Decision Date 08/22/1990
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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