FDA 510(k) Application Details - K032791

Device Classification Name	Control, Hemoglobin   More FDA Info for this Device
510(K) Number	K032791
Device Name	Control, Hemoglobin
Applicant	QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. REDONDO BEACH, CA 90278-1205 US Other 510(k) Applications for this Company
Contact	GEBHARD NEYER Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	GGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2003
Decision Date	10/30/2003
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