FDA 510(k) Application Details - K111128

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K111128
Device Name	Assay, Glycosylated Hemoglobin
Applicant	CERAGEM INTERNATIONAL, INC. 3699 WILSHIRE BLVD.,SUITE 930 LOS ANGELES, CA 90010 US Other 510(k) Applications for this Company
Contact	RAYMOND CHUNG Other 510(k) Applications for this Contact
Regulation Number	864.7470   More FDA Info for this Regulation Number
Classification Product Code	LCP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2011
Decision Date	09/13/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review