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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK081975
Test Name Abbott OptiumEZ Blood Glucose Monitoring System  
Manufacturer NameAbbott Diabetes Care, Inc.
Consumer Information Phone Number1(800)527-3339
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date06/03/2009
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K081975
Device Name RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
Applicant
Abbott Diabetes Care, Inc.
1360 S. Loop Rd.
Alameda,  CA  94502
Applicant Contact ARUL STERLIN
Correspondent
Abbott Diabetes Care, Inc.
1360 S. Loop Rd.
Alameda,  CA  94502
Correspondent Contact ARUL STERLIN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received07/11/2008
Decision Date 11/26/2008
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
Recalls CDRH Recalls
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