The following data is part of a premarket notification filed by Gen-probe with the FDA for Qualitative Test For Hla, Non-diagnostic.
| Device ID | BK120063 |
| 510k Number | BK120063 |
| Device Name: | Qualitative Test For HLA, Non-diagnostic |
| Classification | Test, Qualitative, For Hla, Non-diagnostic |
| Applicant | Gen-Probe 550 West Avenue Stanford, CT 06902 |
| Product Code | MZI |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-26 |
| Decision Date | 2012-11-21 |