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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 K200595
Device Name CellaVision DC-1, CellaVision DC-1 PPA
Applicant
CellaVision AB
Mobilvagen 12
Lund,  SE 22362
Applicant Contact Magnus Johnsson
Correspondent
Axteria BioMed Consulting Inc.
8040 Cobble Creek Circle
Potomac,  MD  20854
Correspondent Contact Jinjie Hu
Regulation Number864.5260
Classification Product Code
JOY  
Date Received03/06/2020
Decision Date 10/16/2020
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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