The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Urine Culture Kit.
| Device ID | K790366 |
| 510k Number | K790366 |
| Device Name: | URINE CULTURE KIT |
| Classification | System, Transport, Aerobic |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | JTW |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-22 |
| Decision Date | 1979-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382903649922 | K790366 | 000 |
| 00382903649891 | K790366 | 000 |
| 00382903649815 | K790366 | 000 |
| 30382903649793 | K790366 | 000 |
| 00382903649464 | K790366 | 000 |
| 30382903649663 | K790366 | 000 |
| 30382903650171 | K790366 | 000 |