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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 K092868
Device Name CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
Applicant
CELLAVISION AB
435 RICE CREEK TERRACE NE
FRIDLEY,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
CELLAVISION AB
435 RICE CREEK TERRACE NE
FRIDLEY,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number864.5260
Classification Product Code
JOY  
Subsequent Product Code
GKZ  
Date Received09/18/2009
Decision Date 11/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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