The following data is part of a premarket notification filed by American Red Cross Blood Services with the FDA for Qualitative Test For Hla, Non-diagnostic.
| Device ID | BK820016 |
| 510k Number | BK820016 |
| Device Name: | Qualitative Test For HLA, Non-diagnostic |
| Classification | Test, Qualitative, For Hla, Non-diagnostic |
| Applicant | American Red Cross Blood Services 15601 Crabbs Branch Way Rockville, MD 20855 |
| 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 | 1983-03-04 |
| Decision Date | 1983-06-01 |