FDA 510(k) Application Details - K080911

Device Classification Name	Abnormal Hemoglobin Quantitation   More FDA Info for this Device
510(K) Number	K080911
Device Name	Abnormal Hemoglobin Quantitation
Applicant	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US Other 510(k) Applications for this Company
Contact	J.B BARTILSON 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	04/02/2008
Decision Date	05/02/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review