FDA 510(k) Application Details - K140198

Device Classification Name	More FDA Info for this Device
510(K) Number	K140198
Device Name	IMDX HSV-1/2 FOR ABBOTT M2000
Applicant	Intelligent Medical Devices, Inc. 180 CABOT ST BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	FRAN WHITE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2014
Decision Date	05/13/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review