The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Max Extended Enteric Bacterial Panel, Bd Max System.
| Device ID | K170308 |
| 510k Number | K170308 |
| Device Name: | BD MAX Extended Enteric Bacterial Panel, BD MAX System |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | BECTON, DICKINSON AND COMPANY 7 LOVETON CIRCLE Sparks, MD 21152 |
| Contact | Laura Stewart |
| Correspondent | Laura Stewart 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 | 2017-02-01 |
| Decision Date | 2017-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904438128 | K170308 | 000 |