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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic esterase--oxidase, cholesterol
510(k) Number K051376
Device Name ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact JENNIFER TRIBBETT
Correspondent
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact JENNIFER TRIBBETT
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Codes
CGA   NBW  
Date Received05/26/2005
Decision Date 08/23/2005
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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