FDA 510(k) Application Details - K232898

Device Classification Name	More FDA Info for this Device
510(K) Number	K232898
Device Name	QuantisalÖ Oral Fluid Collection Device
Applicant	Immunalysis Corporation (an Abbott Rapid Diagnostics company, formerly Alere, Inc.) 829 Towne Center Drive Pomona, CA 91767 US Other 510(k) Applications for this Company
Contact	Shubhajit Mitra Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2023
Decision Date	11/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review