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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 K151639
Device Name ABL80 FLEX and ABL80 FLEX CO-OX
Applicant
Sendx Medical, Inc.
1945 Palomar Oaks Way
Carlsbad,  CA  92011
Applicant Contact VIBEKE AGERLIN
Correspondent
Radiometer Medical Aps
Akandevej 21
Bronshoj,  DK 2700
Correspondent Contact SOREN BOGESTRAND
Regulation Number862.1345
Classification Product Code
CGA  
Date Received06/18/2015
Decision Date 12/07/2015
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
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