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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, automated platelet counting
510(k) Number K014203
Device Name ABX MICROS 60 HEMATOLOGY ANALYZER
Original Applicant
ABX DIAGNOSTICS
34 bunsen dr.
irvine,  CA  92618 4210
Original Contact tom m phillips
Regulation Number864.5200
Classification Product Code
GKX  
Date Received12/21/2001
Decision Date 02/28/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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