FDA 510(k) Application Details - K231013

Device Classification Name	More FDA Info for this Device
510(K) Number	K231013
Device Name	DNA/RNA Shield SafeCollect Saliva Collection kit
Applicant	Zymo Research 17062 Murphy Ave Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Julie Ogi 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	04/10/2023
Decision Date	09/28/2023
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