FDA 510(k) Applications for Medical Device Product Code "PMN"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K152679 | BIO-RAD LABORATORIES | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak | 05/10/2016 |
| DEN150058 | Bio-Rad Laboratories | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak | 03/28/2016 |
| K202382 | BioFire Defense, LLC | FilmArray Global Fever Panel External Control Kit | 11/20/2020 |
| K203680 | Maine Molecular Quality Controls, Inc. | BioFire JI Control Panel M420 | 07/22/2022 |
| K202196 | Maine Molecular Quality Controls, Inc. | BioFire RP2.1/RP2.1plus Control Panel M441 | 06/24/2021 |
| K200010 | Maine Molecular Quality Controls, Inc. | FilmArray BCID2 Control Panel M416 | 04/02/2020 |
| K190222 | Maine Molecular Quality Controls, Inc. | FilmArray Pneumonia/Pneumoniaplus Control | 05/03/2019 |
| K161573 | MAINE MOLECULAR QUALITY CONTROLS, INC. | FilmArray RP EZ Control Panel M265 | 09/02/2016 |
| K173171 | Maine Molecular Quality Controls, Inc. | FilmArray RP2/RP2plus Control Panel | 11/24/2017 |
| K163522 | Maine Molecular Quality Controls, Inc. | FilmArray Warrior Control Panel M290 | 03/14/2017 |
| K221253 | Maine Molecular Quality Controls, Inc. | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | 02/03/2023 |
| K230868 | Maine Molecular Quality Controls, Inc. | SPOTFIRE« RSP Pos & Neg Controls, SPOTFIRE« RSP Positive Control, SPOTFIRE« RSP Negative Control | 04/13/2023 |
| K181683 | Microbiologics, Inc. | BD MAX CT/GC/TV 20-Day QC Panel | 08/28/2018 |
| K181711 | Microbiologics, Inc. | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel | 08/15/2018 |
| K190463 | Microbiologics, Inc. | Cepheid Xpert C. difficile/Epi Control Panel | 04/19/2019 |
| K190223 | Microbiologics, Inc. | Cepheid Xpert CT/NG Control Panel | 05/08/2019 |
| K182472 | Microbiologics, Inc. | Cepheid Xpert GBS LB Control Panel | 11/08/2018 |
| K191172 | Microbiologics, Inc. | Cepheid Xpert MRSA NxG Control Panel | 06/20/2019 |
| K190086 | Microbiologics, Inc. | Cepheid Xpert Respiratory Control Panel | 10/07/2019 |
| K191168 | Microbiologics, Inc. | Cepheid Xpert SA Nasal Complete Control Panel | 06/25/2019 |
| K231223 | Streck | MDx-Chex for BC-GN | 07/27/2023 |
| K231221 | Streck | MDx-Chex for BC-GP | 07/27/2023 |
| K212576 | Streck, Inc | MDx-Chex for BCID2 | 01/19/2022 |
| K201403 | Zeptometrix | NATtrol BD MAX Vaginal Panel External Controls | 02/02/2022 |
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