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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K051213
Device Name PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
Applicant
ABBOTT LABORATORIES INC
1360 SOUTH LOOP ROAD
ALAMEDA,  CA  94502
Applicant Contact ANDREA RUTH
Correspondent
ABBOTT LABORATORIES INC
1360 SOUTH LOOP ROAD
ALAMEDA,  CA  94502
Correspondent Contact ANDREA RUTH
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received05/12/2005
Decision Date 05/27/2005
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
Recalls CDRH Recalls
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