FDA 510(k) Application Details - K153150

Device Classification Name	More FDA Info for this Device
510(K) Number	K153150
Device Name	AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
Applicant	Inova Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131 US Other 510(k) Applications for this Company
Contact	Gabriella Lakos Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2015
Decision Date	11/24/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review