The following data is part of a premarket notification filed by Biotechnology Institute, Sl. with the FDA for Blood Specimen Collection Devices - Vacuum.
| Device ID | BK090069 |
| 510k Number | BK090069 |
| Device Name: | Blood Specimen Collection Devices - Vacuum |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Biotechnology Institute, SL. c/leonardo Da Vinci 14b, 1b. 01510 Minano (alava) Alava, 01510, SP |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-11-09 |
| Decision Date | 2010-02-01 |