Data / Medical devices / United States / Maine Molecular Quality Controls, Inc.
Maine Molecular Quality Controls, Inc.: FDA-registered device maker in Saco, ME, United States, 10 510(k) clearances
Maine Molecular Quality Controls, Inc. is registered with the FDA (registration 3005959679) in Saco, ME, United States. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 19, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005959679
- Address
- 23 Mill Brook Rd, Saco, ME, United States, 04072
- Owner or operator
- MAINE MOLECULAR QUALITY CONTROLS, INC. (9081510)
- Roles
- Manufacturer
- First device listed
- December 30, 2009
- Registered through
- 2026
- Brand names listed
- BioFire JI Control Panel M420, BioFire RP2.1/RP2.1plus Control Panel M441, Birlinn BCR-ABL1 p210 IS Control Panel C240, Birlinn BCR-ABL1 p210 IS Panel C230, Birlinn CoV2-Flu-RSV Control Panel M509, FilmArray BCID2 Control Panel M416, FilmArray GI Control Panel M238, FilmArray Pneumonia/Pneumoniaplus Control and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | PMN | 2 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Manufacturer | accessdata.fda.gov |
| Quality Control Material, Genetics, Dna | NZB | 2 | Manufacturer | accessdata.fda.gov |
| Quality Control Material, Genetics, Rna | QIG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 19, 2026 | K260577 | FilmArray TF Control Panel M527 | PMN | Substantially Equivalent | Maine Molecular Quality Controls, Inc. | accessdata.fda.gov |
| August 14, 2025 | K251526 | FilmArray GI Control Panel M238 | PMN | Substantially Equivalent | Maine Molecular Quality Controls, Inc. | accessdata.fda.gov |
| May 30, 2024 | K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | PMN | Substantially Equivalent | Maine Molecular Quality Controls, Inc. | accessdata.fda.gov |
| April 13, 2023 | K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control | PMN | Substantially Equivalent | Maine Molecular Quality Controls, Inc. | accessdata.fda.gov |
| July 22, 2022 | K203680 | BioFire JI Control Panel M420 | PMN | Substantially Equivalent | Maine Molecular Quality Controls, Inc. | accessdata.fda.gov |
| June 24, 2021 | K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | PMN | Substantially Equivalent | Maine Molecular Quality Controls, Inc. | accessdata.fda.gov |
| April 2, 2020 | K200010 | FilmArray BCID2 Control Panel M416 | PMN | Substantially Equivalent | Maine Molecular Quality Controls, Inc. | accessdata.fda.gov |
| May 3, 2019 | K190222 | FilmArray Pneumonia/Pneumoniaplus Control | PMN | Substantially Equivalent | Maine Molecular Quality Controls, Inc. | accessdata.fda.gov |
| March 14, 2017 | K163522 | FilmArray Warrior Control Panel M290 | PMN | Substantially Equivalent | Maine Molecular Quality Controls, Inc. | accessdata.fda.gov |
| December 16, 2008 | K083171 | INTROL CF PANEL I CONTROL, MODEL: G106 | NZB | Substantially Equivalent | Maine Molecular Quality Controls, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- All makers of Multi-Analyte Controls Unassayed
- All makers of Quality Control Material, Genetics, Dna
Updated May 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.