The following data is part of a premarket notification filed by Lab 21 Healthcare Ltd with the FDA for Test, Syphilis, Treponema (for Donor Testing).
| Device ID | BK100024 |
| 510k Number | BK100024 |
| Device Name: | Test, Syphilis, Treponema (FOR DONOR TESTING) |
| Classification | Test, Donor, Syphilis, Antigens, Treponemal |
| Applicant | Lab 21 Healthcare Ltd 184 Cambridge Science Park Cambridge, Cambridgeshire, CB4 0GA, UK, UK |
| Product Code | MYR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-25 |
| Decision Date | 2010-08-03 |