The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Vacutainer Ultratouch Push Button Blood Collection Set.
| Device ID | K212724 |
| 510k Number | K212724 |
| Device Name: | BD Vacutainer UltraTouch Push Button Blood Collection Set |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Katherine Kenner Lemus |
| Correspondent | Katherine Kenner Lemus Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-27 |
| Decision Date | 2022-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903673921 | K212724 | 000 |
| 00382903673643 | K212724 | 000 |
| 00382903673650 | K212724 | 000 |
| 00382903673919 | K212724 | 000 |
| 00382903673926 | K212724 | 000 |
| 30382903686866 | K212724 | 000 |
| 30382903686842 | K212724 | 000 |
| 30382903686859 | K212724 | 000 |
| 30382903686873 | K212724 | 000 |
| 30382903686880 | K212724 | 000 |
| 30382903686897 | K212724 | 000 |
| 00382903673933 | K212724 | 000 |
| 50382903673631 | K212724 | 000 |
| 50382903673648 | K212724 | 000 |
| 50382903673655 | K212724 | 000 |
| 50382903673914 | K212724 | 000 |
| 00382903673636 | K212724 | 000 |