FDA 510(k) Application Details - K172509

Device Classification Name	More FDA Info for this Device
510(K) Number	K172509
Device Name	Sentosa SA201 HSV 1/2 Qualitative PCR Test
Applicant	Vela Diagnostics USA Inc. 353C US Route 46 West Suite 250 Fairfield, NJ 07004 US Other 510(k) Applications for this Company
Contact	Donald Henton 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	08/21/2017
Decision Date	02/01/2018
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