Medical Device Manufacturer · US , Scarborough , ME

Maine Molecular Quality Controls, Inc. - FDA 510(k) Cleared Devices

15 submissions · 14 cleared · Since 2006

Recent clearances: FilmArray TF Control Panel M527, FilmArray GI Control Panel M238, SPOTFIRE RSP Pos & Neg Controls

15

Total

14

Cleared

1

Denied

FDA 510(k) Regulatory Record - Maine Molecular Quality Controls, Inc. Microbiology ✕

13 devices

1-12 of 13

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