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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K070984
Device Name THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
Applicant
Abbott Diabetes Care, Inc.
1360 S. Loop Rd.
Alameda,  CA  94502
Applicant Contact MARIA E TREJO
Correspondent
Abbott Diabetes Care, Inc.
1360 S. Loop Rd.
Alameda,  CA  94502
Correspondent Contact MARIA E TREJO
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received04/06/2007
Decision Date 11/01/2007
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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