Panels › Microbiology › Product code PMN · Class 2
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Regulation 866.3920
5510(k)s in 12 months (32 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in PMN
| Company | 510(k)s | Recalls |
|---|---|---|
| Maine Molecular Quality Controls, Inc. | 13 | 0 |
| Microbiologics, Inc. | 8 | 4 |
| Streck | 6 | 0 |
| Bio-Rad Laboratories | 2 | 0 |
| Biofire Defense, LLC | 2 | 0 |
| Zeptometrix | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 17, 2026 | K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit Biofire Defense, LLC | PMN |
| May 19, 2026 | K260577 | FilmArray TF Control Panel M527 Maine Molecular Quality Controls, Inc. | PMN |
| Mar 27, 2026 | K260041 | MDx-Chex for BCP Streck, LLC | PMN |
| Mar 23, 2026 | K254166 | MDx-Chex for BCN Streck | PMN |
| Mar 17, 2026 | K254167 | MDx-Chex for BCY Streck, LLC | PMN |
| Aug 14, 2025 | K251526 | FilmArray GI Control Panel M238 Maine Molecular Quality Controls, Inc. | PMN |
| May 30, 2024 | K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control Maine Molecular Quality Controls, Inc. | PMN |
| Mar 26, 2024 | K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) Maine Molecular Quality Controls, Inc. | PMN |
| Jul 27, 2023 | K231223 | MDx-Chex for BC-GN Streck | PMN |
| Jul 27, 2023 | K231221 | MDx-Chex for BC-GP Streck | PMN |
| Apr 13, 2023 | K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control Maine Molecular Quality Controls, Inc. | PMN |
| Feb 3, 2023 | K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control Maine Molecular Quality Controls, Inc. | PMN |
| Jul 22, 2022 | K203680 | BioFire JI Control Panel M420 Maine Molecular Quality Controls, Inc. | PMN |
| Feb 2, 2022 | K201403 | NATtrol BD MAX Vaginal Panel External Controls Zeptometrix | PMN |
| Jan 19, 2022 | K212576 | MDx-Chex for BCID2 Streck, Inc. | PMN |
| Jun 24, 2021 | K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 Maine Molecular Quality Controls, Inc. | PMN |
| Nov 20, 2020 | K202382 | FilmArray Global Fever Panel External Control Kit Biofire Defense, LLC | PMN |
| Apr 2, 2020 | K200010 | FilmArray BCID2 Control Panel M416 Maine Molecular Quality Controls, Inc. | PMN |
| Oct 7, 2019 | K190086 | Cepheid Xpert Respiratory Control Panel Microbiologics, Inc. | PMN |
| Jun 25, 2019 | K191168 | Cepheid Xpert SA Nasal Complete Control Panel Microbiologics, Inc. | PMN |
| Jun 20, 2019 | K191172 | Cepheid Xpert MRSA NxG Control Panel Microbiologics, Inc. | PMN |
| May 8, 2019 | K190223 | Cepheid Xpert CT/NG Control Panel Microbiologics, Inc. | PMN |
| May 3, 2019 | K190222 | FilmArray Pneumonia/Pneumoniaplus Control Maine Molecular Quality Controls, Inc. | PMN |
| Apr 19, 2019 | K190463 | Cepheid Xpert C. difficile/Epi Control Panel Microbiologics, Inc. | PMN |
| Nov 8, 2018 | K182472 | Cepheid Xpert GBS LB Control Panel Microbiologics, Inc. | PMN |
| Aug 28, 2018 | K181683 | BD MAX CT/GC/TV 20-Day QC Panel Microbiologics, Inc. | PMN |
| Aug 15, 2018 | K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel Microbiologics, Inc. | PMN |
| Nov 24, 2017 | K173171 | FilmArray RP2/RP2plus Control Panel Maine Molecular Quality Controls, Inc. | PMN |
| Mar 14, 2017 | K163522 | FilmArray Warrior Control Panel M290 Maine Molecular Quality Controls, Inc. | PMN |
| Sep 2, 2016 | K161573 | FilmArray RP EZ Control Panel M265 Maine Molecular Quality Controls, Inc. | PMN |
| May 10, 2016 | K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak Bio-Rad Laboratories | PMN |
| Mar 28, 2016 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Ampl Bio-Rad Laboratories | PMN |
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