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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK133741
Test Name Roche Diagnostics ACCU-CHEK Performa Blood Glucose Monitoring System  
Manufacturer NameRoche Diagnostics
Consumer Information Phone Number1(800)440-3638
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date09/30/2014
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K133741
Device Name ACCU-CHEK Performa Blood Glucose Monitoring System
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact NATHAN CARRINGTON
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact NATHAN CARRINGTON
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received12/09/2013
Decision Date 08/29/2014
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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