FDA 510(k) Application Details - K183223

Device Classification Name	More FDA Info for this Device
510(K) Number	K183223
Device Name	Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
Applicant	DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 US Other 510(k) Applications for this Company
Contact	Sharon Young Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2018
Decision Date	12/19/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review