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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 K913305
Device Name CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER
Applicant
Unipath , Ltd.
850 Maude Ave.
Mountain View,  CA  94043
Applicant Contact SHERB EDMONDSON
Correspondent
Unipath , Ltd.
850 Maude Ave.
Mountain View,  CA  94043
Correspondent Contact SHERB EDMONDSON
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received07/25/1991
Decision Date 11/22/1991
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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