The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Max(tm) Enteric Bacterial Panel;bd Max(tm) Instrument.
| Device ID | K140111 |
| 510k Number | K140111 |
| Device Name: | BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT |
| Classification | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | Becton, Dickinson And Company 7 LOVETON CIRCLE Sparks, MD 21152 |
| Contact | Paul Swift |
| Correspondent | Paul Swift 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 | 2014-01-15 |
| Decision Date | 2014-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904433789 | K140111 | 000 |
| 00382904429638 | K140111 | 000 |