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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 K991839
Device Name ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
Applicant
Abx Diagnostics
7777 Center Ave.
Suite 102
Huntington Beach,  CA  92647
Applicant Contact PAT AMTOWER
Correspondent
Abx Diagnostics
7777 Center Ave.
Suite 102
Huntington Beach,  CA  92647
Correspondent Contact PAT AMTOWER
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received05/28/1999
Decision Date 08/11/1999
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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