The following data is part of a premarket notification filed by Greiner Bio One North America, Inc. with the FDA for Blood Specimen Collection Devices - Vacuum.
| Device ID | BK050028 |
| 510k Number | BK050028 |
| Device Name: | Blood Specimen Collection Devices - Vacuum |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Greiner Bio One North America, Inc. 4238 Capital Drive Monroe, NC 28110 |
| 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 | 2005-04-14 |
| Decision Date | 2005-07-07 |