The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Max Enteric Viral Panel, Bd Max Instrument.
| Device ID | K181427 |
| 510k Number | K181427 |
| Device Name: | BD MAX Enteric Viral Panel, BD MAX Instrument |
| 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 | 2018-06-01 |
| Decision Date | 2018-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904439859 | K181427 | 000 |