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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 K942525
Device Name MEDICOUNT DEKA HEMATOLOGY ANALYZER
Applicant
Cea America Corp.
5300 Memorial Dr. #310
Houston,  TX  77007
Applicant Contact THOMAS BURTNETT
Correspondent
Cea America Corp.
5300 Memorial Dr. #310
Houston,  TX  77007
Correspondent Contact THOMAS BURTNETT
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received05/27/1994
Decision Date 06/05/1996
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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