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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K032076
Device Name SENOVA(R) BLOOD GLUCOSE MONITOR
Applicant
Chdiagnostics, LLC
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Applicant Contact RICHARD N PHILLIPS
Correspondent
Chdiagnostics, LLC
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Correspondent Contact RICHARD N PHILLIPS
Regulation Number862.1345
Classification Product Code
LFR  
Date Received07/07/2003
Decision Date 09/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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