FDA 510(k) Application Details - K230868

Device Classification Name	More FDA Info for this Device
510(K) Number	K230868
Device Name	SPOTFIRE« RSP Pos & Neg Controls, SPOTFIRE« RSP Positive Control, SPOTFIRE« RSP Negative Control
Applicant	Maine Molecular Quality Controls, Inc. 23 Mill Brook Road Saco, ME 04072 US Other 510(k) Applications for this Company
Contact	Joan Gordon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2023
Decision Date	04/13/2023
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