The following data is part of a premarket notification filed by Immucor Transplant Diagnostics, Inc. with the FDA for Qualitative Test For Hla, Non-diagnostic.
| Device ID | BK150343 |
| 510k Number | BK150343 |
| Device Name: | Qualitative Test For HLA, Non-diagnostic |
| Classification | Test, Qualitative, For Hla, Non-diagnostic |
| Applicant | Immucor Transplant Diagnostics, Inc. 550 West Avenue Stamford, CT 06902 |
| 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 | 2015-11-17 |
| Decision Date | 2016-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234400394 | BK150343 | 0 |