FDA 510(k) Application Details - K091283

Device Classification Name	Abnormal Hemoglobin Quantitation   More FDA Info for this Device
510(K) Number	K091283
Device Name	Abnormal Hemoglobin Quantitation
Applicant	SEBIA 1705 CORPORATE DRIVE SUITE 400 NORCROSS, GA 30093 US Other 510(k) Applications for this Company
Contact	KAREN ANDERSON Other 510(k) Applications for this Contact
Regulation Number	864.7415   More FDA Info for this Regulation Number
Classification Product Code	GKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2009
Decision Date	02/22/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review