Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Maine Molecular Quality Controls, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
323 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260577 | FilmArray TF Control Panel M527 | Maine Molecular Quality Controls, Inc. | 2026-05-19 | 88 | 0 |
| K251526 | FilmArray GI Control Panel M238 | Maine Molecular Quality Controls, Inc. | 2025-08-14 | 87 | 0 |
| K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Contr | Maine Molecular Quality Controls, Inc. | 2024-05-30 | 23 | 0 |
| K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positiv | Maine Molecular Quality Controls, Inc. | 2024-03-26 | 134 | 0 |
| K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Con | Maine Molecular Quality Controls, Inc. | 2023-04-13 | 15 | 0 |
| K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | 2023-02-03 | 277 | 0 |
| K203680 | BioFire JI Control Panel M420 | Maine Molecular Quality Controls, Inc. | 2022-07-22 | 582 | 0 |
| K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | Maine Molecular Quality Controls, Inc. | 2021-06-24 | 323 | 0 |
| K200010 | FilmArray BCID2 Control Panel M416 | Maine Molecular Quality Controls, Inc. | 2020-04-02 | 91 | 0 |
| K190222 | FilmArray Pneumonia/Pneumoniaplus Control | Maine Molecular Quality Controls, Inc. | 2019-05-03 | 87 | 0 |
| K173171 | FilmArray RP2/RP2plus Control Panel | Maine Molecular Quality Controls, Inc. | 2017-11-24 | 56 | 0 |
| K163522 | FilmArray Warrior Control Panel M290 | Maine Molecular Quality Controls, Inc. | 2017-03-14 | 89 | 0 |
| K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016-09-02 | 87 | 0 |
| K083171 | INTROL CF PANEL I CONTROL, MODEL: G106 | Maine Molecular Quality Controls, Inc. | 2008-12-16 | 50 | 0 |
| DEN060007 | INTROL CF PANEL I CONTROL | Maine Molecular Quality Controls, Inc. | 2006-10-12 | 59 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda