The following data is part of a premarket notification filed by One Lambda, Inc with the FDA for Qualitative Test For Hla, Non-diagnostic.
| Device ID | BK120014 |
| 510k Number | BK120014 |
| Device Name: | Qualitative Test For HLA, Non-diagnostic |
| Classification | Test, Qualitative, For Hla, Non-diagnostic |
| Applicant | One Lambda, Inc 21001 Kittridge St Canoga Park, CA 91303 |
| Product Code | MZI |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-12-18 |