The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Bactec Bacterial Detection System.
| Device ID | K792575 |
| 510k Number | K792575 |
| Device Name: | BACTEC BACTERIAL DETECTION SYSTEM |
| Classification | Monitor, Microbial Growth |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | JTA |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-13 |
| Decision Date | 1979-12-27 |