FDA 510(k) Application Details - K211342

Device Classification Name	Campylobacter Spp.   More FDA Info for this Device
510(K) Number	K211342
Device Name	Campylobacter Spp.
Applicant	Quidel Corporation 10165 McKellar Court San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Michelle Bodien Other 510(k) Applications for this Contact
Regulation Number	866.3110   More FDA Info for this Regulation Number
Classification Product Code	LQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2021
Decision Date	11/23/2021
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