FDA 510(k) Applications Submitted by JOAN GORDON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200010 |
01/02/2020 |
FilmArray BCID2 Control Panel M416 |
Maine Molecular Quality Controls, Inc. |
| K190222 |
02/05/2019 |
FilmArray Pneumonia/Pneumoniaplus Control |
Maine Molecular Quality Controls, Inc. |
| K230868 |
03/29/2023 |
SPOTFIRE« RSP Pos & Neg Controls, SPOTFIRE« RSP Positive Control, SPOTFIRE« RSP Negative Control |
Maine Molecular Quality Controls, Inc. |
| K221253 |
05/02/2022 |
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control |
Maine Molecular Quality Controls, Inc. |
| K161573 |
06/07/2016 |
FilmArray RP EZ Control Panel M265 |
MAINE MOLECULAR QUALITY CONTROLS, INC. |
| K202196 |
08/05/2020 |
BioFire RP2.1/RP2.1plus Control Panel M441 |
Maine Molecular Quality Controls, Inc. |
| DEN060007 |
08/14/2006 |
INTROL CF PANEL I CONTROL |
MAINE MOLECULAR QUALITY CONTROLS, INC. |
| K173171 |
09/29/2017 |
FilmArray RP2/RP2plus Control Panel |
Maine Molecular Quality Controls, Inc. |
| K083171 |
10/27/2008 |
INTROL CF PANEL I CONTROL, MODEL: G106 |
MAINE MOLECULAR QUALITY CONTROLS, INC. |
| K163522 |
12/15/2016 |
FilmArray Warrior Control Panel M290 |
Maine Molecular Quality Controls, Inc. |
| K203680 |
12/17/2020 |
BioFire JI Control Panel M420 |
Maine Molecular Quality Controls, Inc. |
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