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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 K032214
Device Name MEDONIC CA620/530 HEMATOLOGY ANALYZER
Applicant
Boule Medical AB
1660 NW 65th Ave. Suite 2
Plantation,  FL  33313
Applicant Contact ANDREW SWANSON
Correspondent
Boule Medical AB
1660 NW 65th Ave. Suite 2
Plantation,  FL  33313
Correspondent Contact ANDREW SWANSON
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received07/21/2003
Decision Date 01/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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