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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 K052207
Device Name ACCUREX GLUCOSE TEST STRIP
Applicant
INCLINE MEDICAL, LLC
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
INCLINE MEDICAL, LLC
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received08/12/2005
Decision Date 03/09/2006
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
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