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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 K052762
Device Name LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
Applicant
Agamatrix, Inc.
230 Albany St.
Cambridge,  MA  02139
Applicant Contact CONNIE HERTEL
Correspondent
Agamatrix, Inc.
230 Albany St.
Cambridge,  MA  02139
Correspondent Contact CONNIE HERTEL
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received09/30/2005
Decision Date 01/23/2006
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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