Panels › Microbiology › Product code PCI · Class 2
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
Regulation 866.3990
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PCI
| Company | 510(k)s | Recalls |
|---|---|---|
| Becton, Dickinson and Company | 3 | 0 |
| Great Basin Scientific, Inc. | 1 | 0 |
| Micronics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 31, 2025 | K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial P Becton, Dickinson and Company | PCI |
| Jul 28, 2022 | K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel Becton, Dickinson and Company | PCI |
| Jun 1, 2018 | K173330 | PanNAT STEC Test Micronics, Inc. | PCI |
| Jul 12, 2017 | K163571 | Great Basin Stool Bacterial Pathogens Panel Great Basin Scientific, Inc. | PCI |
| May 6, 2014 | K140111 | BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT Becton, Dickinson and Company | PCI |
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