FDA 510(k) Application Details - K051072

Device Classification Name	Abnormal Hemoglobin Quantitation   More FDA Info for this Device
510(K) Number	K051072
Device Name	Abnormal Hemoglobin Quantitation
Applicant	BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US Other 510(k) Applications for this Company
Contact	WILLIAM G GUSTAFSON 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	04/26/2005
Decision Date	05/12/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review