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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name method, enzymatic, glucose (urinary, non-quantitative)
510(k) Number K023885
Device Name COMBI-SCREEN, MODELS 10SL AND 11SL
Applicant
ANALYTICON BIOTECHNOLOGIES AG
P.O. BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
ANALYTICON BIOTECHNOLOGIES AG
P.O. BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Code
JIP  
Date Received11/21/2002
Decision Date 10/21/2003
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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