Company · US
Maine Molecular Quality Controls, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2026. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2026 | K262573 | SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control Maine Molecular Quality Controls, Inc. | PMN |
| May 19, 2026 | K260577 | FilmArray TF Control Panel M527 Maine Molecular Quality Controls, Inc. | PMN |
| Aug 14, 2025 | K251526 | FilmArray GI Control Panel M238 Maine Molecular Quality Controls, Inc. | PMN |
| May 30, 2024 | K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control Maine Molecular Quality Controls, Inc. | PMN |
| Mar 26, 2024 | K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) Maine Molecular Quality Controls, Inc. | PMN |
| Apr 13, 2023 | K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control Maine Molecular Quality Controls, Inc. | PMN |
| Feb 3, 2023 | K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control Maine Molecular Quality Controls, Inc. | PMN |
| Jul 22, 2022 | K203680 | BioFire JI Control Panel M420 Maine Molecular Quality Controls, Inc. | PMN |
| Jun 24, 2021 | K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 Maine Molecular Quality Controls, Inc. | PMN |
| Apr 2, 2020 | K200010 | FilmArray BCID2 Control Panel M416 Maine Molecular Quality Controls, Inc. | PMN |
| May 3, 2019 | K190222 | FilmArray Pneumonia/Pneumoniaplus Control Maine Molecular Quality Controls, Inc. | PMN |
| Nov 24, 2017 | K173171 | FilmArray RP2/RP2plus Control Panel Maine Molecular Quality Controls, Inc. | PMN |
| Mar 14, 2017 | K163522 | FilmArray Warrior Control Panel M290 Maine Molecular Quality Controls, Inc. | PMN |
| Sep 2, 2016 | K161573 | FilmArray RP EZ Control Panel M265 Maine Molecular Quality Controls, Inc. | PMN |
| Dec 16, 2008 | K083171 | INTROL CF PANEL I CONTROL, MODEL: G106 Maine Molecular Quality Controls, Inc. | NZB |
| Oct 12, 2006 | DEN060007 | INTROL CF PANEL I CONTROL Maine Molecular Quality Controls, Inc. | NZB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||