The following data is part of a premarket notification filed by Biotest Diagnostics Corporation with the FDA for Qualitative Test For Hla, Non-diagnostic.
| Device ID | BK980033 |
| 510k Number | BK980033 |
| Device Name: | Qualitative Test For HLA, Non-diagnostic |
| Classification | Test, Qualitative, For Hla, Non-diagnostic |
| Applicant | Biotest Diagnostics Corporation 66 Ford Road, Suite 131 Denville, NJ 07834 |
| 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 | 1998-09-04 |
| Decision Date | 1999-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611969965700 | BK980033 | 0 |
| 07611969953189 | BK980033 | 0 |
| 07611969953172 | BK980033 | 0 |
| 07611969952939 | BK980033 | 0 |