Maine Molecular Quality Controls, Inc.
Saco, ME, US
MAINE MOLECULAR QUALITY CONTROLS, INC. appears in FDA device records in Saco, ME. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Maine Molecular Quality Controls, Inc. between 2006 and 2026. The busiest year on record is 2017, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2008 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260577 | FilmArray TF Control Panel M527 | PMN | Substantially Equivalent | |
| K251526 | FilmArray GI Control Panel M238 | PMN | Substantially Equivalent | |
| K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | PMN | Substantially Equivalent | |
| K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) | PMN | Substantially Equivalent | |
| K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control | PMN | Substantially Equivalent | |
| K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | PMN | Substantially Equivalent | |
| K203680 | BioFire JI Control Panel M420 | PMN | Substantially Equivalent | |
| K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | PMN | Substantially Equivalent | |
| K200010 | FilmArray BCID2 Control Panel M416 | PMN | Substantially Equivalent | |
| K190222 | FilmArray Pneumonia/Pneumoniaplus Control | PMN | Substantially Equivalent | |
| K173171 | FilmArray RP2/RP2plus Control Panel | PMN | Substantially Equivalent | |
| K163522 | FilmArray Warrior Control Panel M290 | PMN | Substantially Equivalent | |
| K161573 | FilmArray RP EZ Control Panel M265 | PMN | Substantially Equivalent | |
| K083171 | INTROL CF PANEL I CONTROL, MODEL: G106 | NZB | Substantially Equivalent | |
| DEN060007 | INTROL CF PANEL I CONTROL | NZB | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005959679 | 3005959679 | MAINE MOLECULAR QUALITY CONTROLS, INC. | 23 Mill Brook Rd, Saco, ME 04072 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain