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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K850386
Device Name SYSTEM 8000 CELL COUNTER
Applicant
Baker Instructions Corp.
100 Cascade Dr.
P.O. Box 2168
Allentown,  PA  18001
Applicant Contact TOMALESKY
Correspondent
Baker Instructions Corp.
100 Cascade Dr.
P.O. Box 2168
Allentown,  PA  18001
Correspondent Contact TOMALESKY
Regulation Number864.5200
Classification Product Code
GKL  
Date Received02/01/1985
Decision Date 05/02/1985
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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