The following data is part of a premarket notification filed by Sienna Partners with the FDA for Blood Specimen Collection Devices - Vacuum.
| Device ID | BK040018 |
| 510k Number | BK040018 |
| Device Name: | Blood Specimen Collection Devices - Vacuum |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | sienna Partners p.o. Box 103 Baldwin, MD 21013 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 | 2004-02-26 |
| Decision Date | 2004-07-28 |