FDA 510(k) Application Details - K173330

Device Classification Name	More FDA Info for this Device
510(K) Number	K173330
Device Name	PanNAT STEC Test
Applicant	Micronics, Inc 8464 154th Ave NE Redmond, WA 98052 US Other 510(k) Applications for this Company
Contact	Karen Hedine Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2017
Decision Date	06/01/2018
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