FDA 510(k) Application Details - K171641

Device Classification Name	More FDA Info for this Device
510(K) Number	K171641
Device Name	Accula Flu A/Flu B Test
Applicant	Mesa Biotech, Inc. 6190 Cornerstone Court, Suite 220 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Barbara E. Stevens Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2017
Decision Date	02/06/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review