FDA 510(k) Application Details - K190088

Device Classification Name	System, Test, Rheumatoid Factor   More FDA Info for this Device
510(K) Number	K190088
Device Name	System, Test, Rheumatoid Factor
Applicant	Inova Diagnostics, Inc. 9900 Old Grove Rd. San Diego, CA 92131-1638 US Other 510(k) Applications for this Company
Contact	Roger Albesa Other 510(k) Applications for this Contact
Regulation Number	866.5775   More FDA Info for this Regulation Number
Classification Product Code	DHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2019
Decision Date	04/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review