The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Blood Specimen Collection Devices - Vacuum.
| Device ID | BK980011 |
| 510k Number | BK980011 |
| Device Name: | Blood Specimen Collection Devices - Vacuum |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON DICKINSON VACUTAINER Systems 1 Becton Drive Franklin Lakes, NJ 07417 US |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-29 |
| Decision Date | 1999-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903685894 | BK980011 | 000 |
| 50382903678995 | BK980011 | 000 |