FDA 510(k) Application Details - K003030

Device Classification Name	Control, Hemoglobin   More FDA Info for this Device
510(K) Number	K003030
Device Name	Control, Hemoglobin
Applicant	BIO-RAD 9500 JERONIMO RD. IRVINE, CA 92618-2017 US Other 510(k) Applications for this Company
Contact	ELIZABETH PLATT 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	09/28/2000
Decision Date	11/29/2000
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	N
Expedited Review