Maine Molecular Quality Controls, Inc.
FDA 510(k) & PMA Approved Devices — 12 products
Total Devices12
Categories1
Latest Approval2025-08-14
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K251526 | FilmArray GI Control Panel M238 | PMN | 2025-08-14 | View |
| 510(k) | K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | PMN | 2024-05-30 | View |
| 510(k) | K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) | PMN | 2024-03-26 | View |
| 510(k) | K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control | PMN | 2023-04-13 | View |
| 510(k) | K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | PMN | 2023-02-03 | View |
| 510(k) | K203680 | BioFire JI Control Panel M420 | PMN | 2022-07-22 | View |
| 510(k) | K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | PMN | 2021-06-24 | View |
| 510(k) | K200010 | FilmArray BCID2 Control Panel M416 | PMN | 2020-04-02 | View |
| 510(k) | K190222 | FilmArray Pneumonia/Pneumoniaplus Control | PMN | 2019-05-03 | View |
| 510(k) | K173171 | FilmArray RP2/RP2plus Control Panel | PMN | 2017-11-24 | View |
| 510(k) | K163522 | FilmArray Warrior Control Panel M290 | PMN | 2017-03-14 | View |
| 510(k) | K161573 | FilmArray RP EZ Control Panel M265 | PMN | 2016-09-02 | View |
No matching devices.