Medical Device Manufacturer · US , Scarborough , ME

14 submissions · 13 cleared · Since 2006
14
Total
13
Cleared
1
Denied

Maine Molecular Quality Controls, Inc. has 13 FDA 510(k) cleared microbiology devices. Based in Scarborough, US.

Latest FDA clearance: Aug 2025. 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.

14 devices
1–12 of 14
FilmArray GI Control Panel M238
K251526 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
Aug 2025 87d
SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
K241289 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
May 2024 23d
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
K233611 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
Mar 2024 134d
SPOTFIRE? RSP Pos & Neg Controls, SPOTFIRE? RSP Positive Control, SPOTFIRE? RSP Negative Control
K230868 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
Apr 2023 15d
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
K221253 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
Feb 2023 277d
BioFire JI Control Panel M420
K203680 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
Jul 2022 582d
BioFire RP2.1/RP2.1plus Control Panel M441
K202196 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
Jun 2021 323d
FilmArray BCID2 Control Panel M416
K200010 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
Apr 2020 91d
FilmArray Pneumonia/Pneumoniaplus Control
K190222 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
May 2019 87d
FilmArray RP2/RP2plus Control Panel
K173171 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
Nov 2017 56d
FilmArray Warrior Control Panel M290
K163522 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
Mar 2017 89d
FilmArray RP EZ Control Panel M265
K161573 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · Microbiology
Sep 2016 87d
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