The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Max Enteric Bacterial Panel, Bd Max Extended Enteric Bacterial Panel.
| Device ID | K214122 |
| 510k Number | K214122 |
| Device Name: | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel |
| Classification | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | Becton, Dickinson And Company 7 Loveton Circle Sparks, MD 21152 |
| Contact | Joseph Basore |
| Correspondent | Joseph Basore Becton, Dickinson And Company 7 Loveton Circle Sparks, MD 21152 |
| Product Code | PCI |
| Subsequent Product Code | OOI |
| Subsequent Product Code | PCH |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-30 |
| Decision Date | 2022-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904438128 | K214122 | 000 |
| 00382904429638 | K214122 | 000 |