FDA 510(k) Application Details - K233611

Device Classification Name	More FDA Info for this Device
510(K) Number	K233611
Device Name	SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
Applicant	Maine Molecular Quality Controls, Inc. 23 Mill Brook Rd 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	11/13/2023
Decision Date	03/26/2024
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