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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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