# Maine Molecular Quality Controls, Inc.

- Location (FDA's records): Saco, ME
- FDA decisions: 15 (2008–2026): 15 510(k) clearances
- Product codes: PMN (14), NZB (1)
- 510(k) review time since 2016: median 88 days, against 88 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 13 (12 its own); citations of its devices by later devices: 15 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)

## Firms that cite its devices most
- Biofire Defense, LLC: 1 (https://510kreport.com/company/biofire-defense)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)
- Streck: 1 (https://510kreport.com/company/streck)

## Its most-cited devices
- K161573: FilmArray RP EZ Control Panel M265 (2016), cited by 3
- K202196: BioFire RP2.1/RP2.1plus Control Panel M441 (2021), cited by 2
- K200010: FilmArray BCID2 Control Panel M416 (2020), cited by 2
- K083171: Introl CF Panel I Control, Model: G106 (2008), cited by 1
- K221253: SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (2023), cited by 1
- K190222: FilmArray Pneumonia/Pneumoniaplus Control (2019), cited by 1

## Recent decisions
- K262573: SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (Oct 21, 2026)
- K260577: FilmArray TF Control Panel M527 (May 19, 2026)
- K251526: FilmArray GI Control Panel M238 (Aug 14, 2025)
- K241289: SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control (May 30, 2024)
- K233611: SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) (Mar 26, 2024)
- K230868: SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control (Apr 13, 2023)
- K221253: SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (Feb 3, 2023)
- K203680: BioFire JI Control Panel M420 (Jul 22, 2022)

Source page: https://510kreport.com/company/maine-molecular-quality-controls