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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K163633
Device Name cobas HbA1c Test, cobas b 101 system
Applicant
Roche Diagnostics Operations
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact Patty Bates
Correspondent
Roche Diagnostics Operations
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact Patty Bates
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JJE  
Date Received12/22/2016
Decision Date 07/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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