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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name method, enzymatic, glucose (urinary, non-quantitative)
510(k) Number K183432
Device Name cobas u 601 urinalysis test system
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact Angela Clements
Correspondent
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact Angela Clements
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JIR  
JJB   JMT   KQO   LJX  
Date Received12/11/2018
Decision Date 05/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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