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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K111128
Device Name LABONACHECK A1C
Applicant
CERAGEM INTERNATIONAL, INC.
3699 WILSHIRE BLVD.,SUITE 930
LOS ANGELES,  CA  90010
Applicant Contact RAYMOND CHUNG
Correspondent
CERAGEM INTERNATIONAL, INC.
3699 WILSHIRE BLVD.,SUITE 930
LOS ANGELES,  CA  90010
Correspondent Contact RAYMOND CHUNG
Regulation Number864.7470
Classification Product Code
LCP  
Date Received04/21/2011
Decision Date 09/13/2012
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
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