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Maine Molecular Quality Controls, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251526FilmArray GI Control Panel M238August 14, 2025
K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMay 30, 2024
K233611SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP NegativMarch 26, 2024
K230868SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative ControlApril 13, 2023
K221253SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlFebruary 3, 2023
K203680BioFire JI Control Panel M420July 22, 2022
K202196BioFire RP2.1/RP2.1plus Control Panel M441June 24, 2021
K200010FilmArray BCID2 Control Panel M416April 2, 2020
K190222FilmArray Pneumonia/Pneumoniaplus ControlMay 3, 2019
K173171FilmArray RP2/RP2plus Control PanelNovember 24, 2017
K163522FilmArray Warrior Control Panel M290March 14, 2017
K161573FilmArray RP EZ Control Panel M265September 2, 2016
K083171INTROL CF PANEL I CONTROL, MODEL: G106December 16, 2008
DEN060007INTROL CF PANEL I CONTROLOctober 12, 2006