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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 K882612
Device Name SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER
Applicant
Baker Instructions Corp.
3085 Shawnee Dr.
P.O. Box 2867
Winchester,  VA  22601
Applicant Contact TOMALESKY
Correspondent
Baker Instructions Corp.
3085 Shawnee Dr.
P.O. Box 2867
Winchester,  VA  22601
Correspondent Contact TOMALESKY
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received06/24/1988
Decision Date 09/07/1988
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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