FDA 510(k) Application Details - K193081

Device Classification Name	More FDA Info for this Device
510(K) Number	K193081
Device Name	Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
Applicant	Rheonix, Inc 10 Brown Road, Suite 103 Ithaca, NY 14850 US Other 510(k) Applications for this Company
Contact	Richard Montagna Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2019
Decision Date	12/17/2021
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