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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, urine particle
510(k) Number K200811
Device Name cobas u 701 microscopy analyzer
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46256
Applicant Contact Teresa Carrow
Correspondent
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46256
Correspondent Contact Teresa Carrow
Regulation Number864.5200
Classification Product Code
LKM  
Date Received03/27/2020
Decision Date 11/06/2020
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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