FDA 510(k) Application Details - K121752

Device Classification Name	System, Hemoglobin, Automated   More FDA Info for this Device
510(K) Number	K121752
Device Name	System, Hemoglobin, Automated
Applicant	MEC DYNAMICS CORP 90 ROSE ORCHARD WAY SAN JOSE, CA 95134 US Other 510(k) Applications for this Company
Contact	EMMANUAL MPOCK 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	06/14/2012
Decision Date	01/07/2013
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