FDA 510(k) Application Details - K052838

Device Classification Name	Control, Hemoglobin   More FDA Info for this Device
510(K) Number	K052838
Device Name	Control, Hemoglobin
Applicant	BIO-RAD 9500 JERONIMO RD. IRVINE, CA 92618-2017 US Other 510(k) Applications for this Company
Contact	MARIA ZEBALLOS 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	10/07/2005
Decision Date	11/09/2005
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