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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
Predetermined Change
Control Plan Authorized		 No
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