FDA 510(k) Application Details - K223497

Device Classification Name	More FDA Info for this Device
510(K) Number	K223497
Device Name	Spectrum Saliva Collection Device
Applicant	Spectrum Solutions, LLC 12248 South Lone Peak Pkwy, Ste 106 Draper, UT 84020 US Other 510(k) Applications for this Company
Contact	Katie Compton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2022
Decision Date	02/17/2023
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