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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
Applicant
ABX DIAGNOSTICS
34 BUNSEN DR.
IRVINE,  CA  92618 -4210
Applicant Contact TOM M PHILLIPS
Correspondent
ABX DIAGNOSTICS
34 BUNSEN DR.
IRVINE,  CA  92618 -4210
Correspondent Contact TOM M PHILLIPS
Regulation Number864.5200
Classification Product Code
GKX  
Date Received12/21/2001
Decision Date 02/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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