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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name glucose oxidase, glucose
510(k) Number K013068
Device Name BIOSCANNER 2000
Original Applicant
7736 zionsville rd.
indianapolis,  IN  46268
Original Contact margo enright
Regulation Number862.1345
Classification Product Code
Subsequent Product Code
Date Received06/28/2001
Decision Date 11/20/2001
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls