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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 K003677
Device Name ABX PENTRA 60C+ HEMATOLOGY ANALYZER
Applicant
Abx Diagnostics
34 Bunsen Dr.
Irvine,  CA  92618
Applicant Contact BRUCE H DAVIS
Correspondent
Abx Diagnostics
34 Bunsen Dr.
Irvine,  CA  92618
Correspondent Contact BRUCE H DAVIS
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received11/29/2000
Decision Date 12/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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