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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, differential cell
510(k) Number K171655
Device Name cobas m 511 integrated hematology analyzer
Applicant
Roche Diagnostics Hematology, Inc.
69 Milk Street, Suite 120
Westborough,  MA  01581
Applicant Contact Dan Bracco
Correspondent
Roche Diagnostics Hematology, Inc.
69 Milk Street, Suite 120
Westborough,  MA  01581
Correspondent Contact Dan Bracco
Regulation Number864.5220
Classification Product Code
GKZ  
Subsequent Product Code
JOY  
Date Received06/05/2017
Decision Date 03/02/2018
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
Recalls CDRH Recalls
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