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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK043311
Test Name BAYER DIAGNOSTICS ASCENSIA ELITE DIABETES CARE SYSTEM  
Manufacturer NameBayer Healthcare, LLC
Consumer Information Phone NumberNO PHONE NUMBER
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date12/29/2004
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K043311
Device Name ASCENSIA ELITE DIABETES CARE SYSTEM
Applicant
Bayer Healthcare, LLC
1884 Miles Ave.
P.O. Box 70
Elkhart,  IN  46514 -0070
Applicant Contact GEORGE M TANCOS
Correspondent
Bayer Healthcare, LLC
1884 Miles Ave.
P.O. Box 70
Elkhart,  IN  46514 -0070
Correspondent Contact GEORGE M TANCOS
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received12/01/2004
Decision Date 12/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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