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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 K051651
Device Name G4, MODEL IGM-0004
Applicant
U. S. DIAGNOSTICS, INC.
304 PARK AVENUE SOUTH
SUITE 218
NEW YORK,  NY  10010
Applicant Contact EDWARD LETKO
Correspondent
U. S. DIAGNOSTICS, INC.
304 PARK AVENUE SOUTH
SUITE 218
NEW YORK,  NY  10010
Correspondent Contact EDWARD LETKO
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received06/21/2005
Decision Date 04/14/2006
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
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