FDA 510(k) Application Details - K240797

Device Classification Name	More FDA Info for this Device
510(K) Number	K240797
Device Name	PPH Saliva Collection Kit
Applicant	Permantis Public Health PO Box 941 New York, NY 10021 US Other 510(k) Applications for this Company
Contact	Robert Darnell 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	03/22/2024
Decision Date	10/11/2024
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