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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, 1,5-Anhydroglucitol (15ag)
510(k) Number K031604
Device Name GLYCOMARK
Applicant
TOMEN AMERICA INC.
1285 AVENUE OF THE AMERICAS
NEW YORK,  NY  10019 -6028
Applicant Contact Erika B Ammirati
Correspondent
TOMEN AMERICA INC.
1285 AVENUE OF THE AMERICAS
NEW YORK,  NY  10019 -6028
Correspondent Contact Erika B Ammirati
Regulation Number864.7470
Classification Product Code
NOZ  
Subsequent Product Codes
JIS   JJX  
Date Received05/22/2003
Decision Date 09/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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