FDA 510(k) Application Details - K100547

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K100547
Device Name	Assay, Glycosylated Hemoglobin
Applicant	SEPPIM S.A.S. 21720 23RD DR SE SUITE 150 BOTHELL, WA 98021 US Other 510(k) Applications for this Company
Contact	DEBRA K HUTSON 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	02/25/2010
Decision Date	05/19/2011
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