FDA 510(k) Application Details - K092116

Device Classification Name	Device, Automated Cell-Locating   More FDA Info for this Device
510(K) Number	K092116
Device Name	Device, Automated Cell-Locating
Applicant	MEDICA CORP. 163 CABOT STREET BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	FRAN WHITE Other 510(k) Applications for this Contact
Regulation Number	864.5260   More FDA Info for this Regulation Number
Classification Product Code	JOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2009
Decision Date	05/12/2010
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