FDA Product Code
FDA Product Code PMN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3920
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC | 2026-07-17 | Traditional | PDF ↗ |
| K260577 | FilmArray TF Control Panel M527 | Maine Molecular Quality Controls, Inc. | 2026-05-19 | Traditional | PDF ↗ |
| K260041 | MDx-Chex for BCP | Streck, LLC | 2026-03-27 | Traditional | PDF ↗ |
| K254166 | MDx-Chex for BCN | Streck | 2026-03-23 | Traditional | PDF ↗ |
| K254167 | MDx-Chex for BCY | Streck, LLC | 2026-03-17 | Traditional | PDF ↗ |
| K251526 | FilmArray GI Control Panel M238 | Maine Molecular Quality Controls, Inc. | 2025-08-14 | Traditional | PDF ↗ |
| K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | 2024-05-30 | Special | PDF ↗ |
| K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) | Maine Molecular Quality Controls, Inc. | 2024-03-26 | Traditional | PDF ↗ |
| K231221 | MDx-Chex for BC-GP | Streck | 2023-07-27 | Traditional | PDF ↗ |
| K231223 | MDx-Chex for BC-GN | Streck | 2023-07-27 | Traditional | PDF ↗ |
| K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control | Maine Molecular Quality Controls, Inc. | 2023-04-13 | Special | PDF ↗ |
| K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | 2023-02-03 | Traditional | PDF ↗ |
| K203680 | BioFire JI Control Panel M420 | Maine Molecular Quality Controls, Inc. | 2022-07-22 | Traditional | PDF ↗ |
| K201403 | NATtrol BD MAX Vaginal Panel External Controls | Zeptometrix | 2022-02-02 | Traditional | PDF ↗ |
| K212576 | MDx-Chex for BCID2 | Streck, Inc. | 2022-01-19 | Traditional | PDF ↗ |
| K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | Maine Molecular Quality Controls, Inc. | 2021-06-24 | Traditional | PDF ↗ |
| K202382 | FilmArray Global Fever Panel External Control Kit | Biofire Defense, LLC | 2020-11-20 | Traditional | PDF ↗ |
| K200010 | FilmArray BCID2 Control Panel M416 | Maine Molecular Quality Controls, Inc. | 2020-04-02 | Traditional | PDF ↗ |
| K190086 | Cepheid Xpert Respiratory Control Panel | Microbiologics, Inc. | 2019-10-07 | Traditional | PDF ↗ |
| K191168 | Cepheid Xpert SA Nasal Complete Control Panel | Microbiologics, Inc. | 2019-06-25 | Traditional | PDF ↗ |
| K191172 | Cepheid Xpert MRSA NxG Control Panel | Microbiologics, Inc. | 2019-06-20 | Traditional | PDF ↗ |
| K190223 | Cepheid Xpert CT/NG Control Panel | Microbiologics, Inc. | 2019-05-08 | Traditional | PDF ↗ |
| K190222 | FilmArray Pneumonia/Pneumoniaplus Control | Maine Molecular Quality Controls, Inc. | 2019-05-03 | Traditional | PDF ↗ |
| K190463 | Cepheid Xpert C. difficile/Epi Control Panel | Microbiologics, Inc. | 2019-04-19 | Traditional | PDF ↗ |
| K182472 | Cepheid Xpert GBS LB Control Panel | Microbiologics, Inc. | 2018-11-08 | Traditional | PDF ↗ |
| K181683 | BD MAX CT/GC/TV 20-Day QC Panel | Microbiologics, Inc. | 2018-08-28 | Traditional | PDF ↗ |
| K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel | Microbiologics, Inc. | 2018-08-15 | Traditional | PDF ↗ |
| K173171 | FilmArray RP2/RP2plus Control Panel | Maine Molecular Quality Controls, Inc. | 2017-11-24 | Traditional | PDF ↗ |
| K163522 | FilmArray Warrior Control Panel M290 | Maine Molecular Quality Controls, Inc. | 2017-03-14 | Traditional | PDF ↗ |
| K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016-09-02 | Traditional | PDF ↗ |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak | Bio-Rad Laboratories | 2016-05-10 | Traditional | PDF ↗ |
| DEN150058 | 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 | Bio-Rad Laboratories | 2016-03-28 | Post-NSE | — |
Product code PMN · Class II · Microbiology. Data: openFDA.