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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 K981568
Device Name MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800
Applicant
CDC TECHNOLOGIES, INC.
1250 24TH STREET, N.W. 7TH FL
WASHINGTON,  DC  20037
Applicant Contact GEORGE J WALLACE
Correspondent
CDC TECHNOLOGIES, INC.
1250 24TH STREET, N.W. 7TH FL
WASHINGTON,  DC  20037
Correspondent Contact GEORGE J WALLACE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received05/01/1998
Decision Date 08/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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