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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
Recalls CDRH Recalls
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