Maine Molecular Quality Controls, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Maine Molecular Quality Controls, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FilmArray TF Control Panel M527, FilmArray GI Control Panel M238, SPOTFIRE RSP Pos & Neg Controls
15
Total
14
Cleared
1
Denied
Maine Molecular Quality Controls, Inc. has 14 FDA 510(k) cleared microbiology devices. Based in Scarborough, US.
Latest FDA clearance: May 2026. Active since 2006.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Maine Molecular Quality Controls, Inc.
15 devices
Cleared
May 19, 2026
FilmArray TF Control Panel M527
Microbiology
88d
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
Cleared
Dec 16, 2008
INTROL CF PANEL I CONTROL, MODEL: G106
Pathology
50d
Not Cleared
Oct 12, 2006
INTROL CF PANEL I CONTROL
Pathology
59d