Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Maine Molecular Quality Controls, Inc.

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories1
Latest FDA decision2026-05-19
TypeNumberDevice NameCodeDateActions
510(k) K260577 FilmArray TF Control Panel M527PMN2026-05-19 View
510(k) K251526 FilmArray GI Control Panel M238PMN2025-08-14 View
510(k) K241289 SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlPMN2024-05-30 View
510(k) K233611 SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)PMN2024-03-26 View
510(k) K230868 SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative ControlPMN2023-04-13 View
510(k) K221253 SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlPMN2023-02-03 View
510(k) K203680 BioFire JI Control Panel M420PMN2022-07-22 View
510(k) K202196 BioFire RP2.1/RP2.1plus Control Panel M441PMN2021-06-24 View
510(k) K200010 FilmArray BCID2 Control Panel M416PMN2020-04-02 View
510(k) K190222 FilmArray Pneumonia/Pneumoniaplus ControlPMN2019-05-03 View
510(k) K173171 FilmArray RP2/RP2plus Control PanelPMN2017-11-24 View
510(k) K163522 FilmArray Warrior Control Panel M290PMN2017-03-14 View
510(k) K161573 FilmArray RP EZ Control Panel M265PMN2016-09-02 View
↑