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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 K063276
Device Name CLINITEK ADVANTUS, MODEL 1420
Applicant
Bayer Healthcare, LLC
2 Edgewater Dr.
Norwood,  MA  02062 -4658
Applicant Contact NOOR MALKI
Correspondent
Bayer Healthcare, LLC
2 Edgewater Dr.
Norwood,  MA  02062 -4658
Correspondent Contact NOOR MALKI
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JFY   JIN   JIO  
JIR   JJB   JMT   JRE   KQO   LJX  
Date Received10/30/2006
Decision Date 12/28/2006
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
Predetermined Change
Control Plan Authorized		 No
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