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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 K880616
Device Name MINOS AUTOMATIC CELL COUNTER
Applicant
Abx, Inc.
355 Business Center Dr.
Horsham,  PA  19044
Applicant Contact WILLIAM M DOUGHERTY
Correspondent
Abx, Inc.
355 Business Center Dr.
Horsham,  PA  19044
Correspondent Contact WILLIAM M DOUGHERTY
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/16/1988
Decision Date 05/02/1988
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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