FDA Product Code
FDA Product Code PCI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3990
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | Becton, Dickinson and Company | 2025-10-31 | Traditional | PDF ↗ |
| K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | Becton, Dickinson and Company | 2022-07-28 | Traditional | PDF ↗ |
| K173330 | PanNAT STEC Test | Micronics, Inc. | 2018-06-01 | Traditional | PDF ↗ |
| K163571 | Great Basin Stool Bacterial Pathogens Panel | Great Basin Scientific, Inc. | 2017-07-12 | Traditional | PDF ↗ |
| K140111 | BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT | Becton, Dickinson and Company | 2014-05-06 | Traditional | PDF ↗ |
Product code PCI · Class II · Microbiology. Data: openFDA.