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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK090628
Test Name Bayer Didget Blood Glucose Monitoring System  
Manufacturer NameBayer Healthcare, LLC
Consumer Information Phone Number1(800)348-8100
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date02/01/2010
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K090628
Device Name DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
Applicant
Bayer Healthcare, LLC
777 Old Saw Mill River Rd.
Tarrytown,  NY  10591
Applicant Contact SUSAN BROCCHI
Correspondent
Bayer Healthcare, LLC
777 Old Saw Mill River Rd.
Tarrytown,  NY  10591
Correspondent Contact SUSAN BROCCHI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received03/09/2009
Decision Date 12/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00985257
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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