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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 K082201
Device Name G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
Applicant
U. S. Diagnostics, Inc.
304 Park Ave. S., Suite 218
New York,  NY  10010
Applicant Contact JONATHAN J JOHNSON
Correspondent
U. S. Diagnostics, Inc.
304 Park Ave. S., Suite 218
New York,  NY  10010
Correspondent Contact JONATHAN J JOHNSON
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received08/05/2008
Decision Date 02/20/2009
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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