The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Qualitative Test For Hla, Non-diagnostic.
| Device ID | BK940015 |
| 510k Number | BK940015 |
| Device Name: | Qualitative Test For HLA, Non-diagnostic |
| Classification | Test, Qualitative, For Hla, Non-diagnostic |
| Applicant | Becton Dickinson Immunocytometry Systems 2350 Qume Drive San Jose, CA 95131 |
| 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 | 1994-03-30 |
| Decision Date | 1994-10-24 |