The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Qualitative Test For Hla, Non-diagnostic.
| Device ID | BK950005 |
| 510k Number | BK950005 |
| Device Name: | Qualitative Test For HLA, Non-diagnostic |
| Classification | Test, Qualitative, For Hla, Non-diagnostic |
| Applicant | Genetic Testing Institute 1701 W. Wisconsin Avenue, Suite 429 Milwaukee, WI 53233 |
| 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 | 1994-10-26 |
| Decision Date | 1995-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234500094 | BK950005 | 0 |