The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Max Enteric Viral Panel.
| Device ID | K220607 |
| 510k Number | K220607 |
| Device Name: | BD MAX Enteric Viral Panel |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | Becton, Dickinson And Company 7 Loveton Circle Sparks, MD 21152 |
| Contact | Joseph Basore |
| Correspondent | Mark Sistare Becton, Dickinson And Company 7 Loveton Circle Sparks, MD 21152 |
| Product Code | PCH |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-02 |
| Decision Date | 2022-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904439859 | K220607 | 000 |