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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
Applicant
Cella Vision AB
Ideon Science Park
Lund,  SE SE-223 70
Applicant Contact Cella Vision AB
Correspondent
CG Bundy LLC
435 Rice Creek Terrace NE
Fridley,  MN  55432
Correspondent Contact Constance G. Bundy
Regulation Number864.5260
Classification Product Code
JOY  
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
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