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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K071652
Device Name HEMOCUE WBC SYSTEM
Applicant
Hemocue AB
40 Empire Dr.
Lake Forest,  CA  92630
Applicant Contact ALLAN WHITE
Correspondent
Hemocue AB
40 Empire Dr.
Lake Forest,  CA  92630
Correspondent Contact ALLAN WHITE
Regulation Number864.5200
Classification Product Code
GKL  
Date Received06/18/2007
Decision Date 10/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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