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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K123136
Device Name GENESIS HEALTH RECORD SYSTEM, (GHRS)
Applicant
Genesis Health Technologies
P.O. Ox 2042
Fairfield,  IA  52556
Applicant Contact KATHLEEN JOHNSON
Correspondent
Genesis Health Technologies
P.O. Ox 2042
Fairfield,  IA  52556
Correspondent Contact KATHLEEN JOHNSON
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received10/05/2012
Decision Date 03/07/2013
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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