The following data is part of a premarket notification filed by Accugenics, Inc. with the FDA for Test, Qualitative, For Hla, Non-diagnostic.
| Device ID | BK820004 |
| 510k Number | BK820004 |
| Device Name: | Test, Qualitative, For HLA, Non-Diagnostic |
| Classification | Test, Qualitative, For Hla, Non-diagnostic |
| Applicant | Accugenics, Inc. Costa Mesa, CA 92626 |
| 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 | 1982-07-22 |
| Decision Date | 1982-10-29 |