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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 K092602
Device Name FREESTYLE LITE BLOOD GLUCOSE TEST STRIPS, MODELS 100 COUNT: 70827-22, 70827-23, 50 COUNT, 70819-20, 70822-22
Original Applicant
1360 south loop rd.
alameda,  CA  94502
Original Contact arul sterlin
Regulation Number862.1345
Classification Product Code
Subsequent Product Code
Date Received08/25/2009
Decision Date 05/14/2010
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
Recalls CDRH Recalls