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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 K171315
Device Name Advanced RBC Application
Cella Vision AB
Ideon Science Park
lund,  SE se-223 70
Applicant Contact cella vision ab
CG Bundy LLC
435 Rice Creek Terrace NE
fridley,  MN  55432
Correspondent Contact constance g. bundy
Regulation Number864.5260
Classification Product Code
Date Received05/04/2017
Decision Date 08/01/2017
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