Maine Molecular Quality Controls, Inc. - FDA 510(k) Cleared Devices
14
Total
13
Cleared
1
Denied
FDA 510(k) cleared devices by Maine Molecular Quality Controls, Inc. Microbiology ✕
12 devices
Cleared
Aug 14, 2025
FilmArray GI Control Panel M238
Microbiology
87d
Cleared
May 30, 2024
SPOTFIRE RSP Pos & Neg Controls
Microbiology
23d
Cleared
Mar 26, 2024
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control...
Microbiology
134d
Cleared
Apr 13, 2023
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE®...
Microbiology
15d
Cleared
Feb 03, 2023
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
Microbiology
277d
Cleared
Jul 22, 2022
BioFire JI Control Panel M420
Microbiology
582d
Cleared
Jun 24, 2021
BioFire RP2.1/RP2.1plus Control Panel M441
Microbiology
323d
Cleared
Apr 02, 2020
FilmArray BCID2 Control Panel M416
Microbiology
91d
Cleared
May 03, 2019
FilmArray Pneumonia/Pneumoniaplus Control
Microbiology
87d
Cleared
Nov 24, 2017
FilmArray RP2/RP2plus Control Panel
Microbiology
56d
Cleared
Mar 14, 2017
FilmArray Warrior Control Panel M290
Microbiology
89d
Cleared
Sep 02, 2016
FilmArray RP EZ Control Panel M265
Microbiology
87d