FDA 510(k) Application Details - K020710

Device Classification Name	System, Hemoglobin, Automated   More FDA Info for this Device
510(K) Number	K020710
Device Name	System, Hemoglobin, Automated
Applicant	BIOTEST MEDIZINTECHNIK GMBH 614 N 4TH ST. RICHMOND, VA 23219 US Other 510(k) Applications for this Company
Contact	MARK LICATA Other 510(k) Applications for this Contact
Regulation Number	864.5620   More FDA Info for this Regulation Number
Classification Product Code	GKR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2002
Decision Date	08/14/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review