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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, automated cell-locating
510(k) Number K080595
FOIA Releasable 510(k) K080595
Device Name CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
Applicant
CELLAVISION AB
6740 RIVERVIEW TERRACE
MINNEAPOLIS,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
CELLAVISION AB
6740 RIVERVIEW TERRACE
MINNEAPOLIS,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number864.5260
Classification Product Code
JOY  
Subsequent Product Code
GKZ  
Date Received03/03/2008
Decision Date 12/05/2008
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
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