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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 K864579
Device Name MINOS AUTOMATIC CELL COUNTER
Applicant
ABX, INC.
R.D. #3 BOX 416
RINGOES,  NJ  08551
Applicant Contact RANDOLPH L COOKE
Correspondent
ABX, INC.
R.D. #3 BOX 416
RINGOES,  NJ  08551
Correspondent Contact RANDOLPH L COOKE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received11/20/1986
Decision Date 07/16/1987
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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