The following data is part of a premarket notification filed by Immucor Gti Diagnostics, Inc. with the FDA for Qualitative Test For Hla, Non-diagnostic.
| Device ID | BK190439 |
| 510k Number | BK190439 |
| Device Name: | Qualitative Test For HLA, Non-diagnostic |
| Classification | Test, Qualitative, For Hla, Non-diagnostic |
| Applicant | Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha, WI 53186 |
| Product Code | MZI |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-27 |
| Decision Date | 2020-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234500803 | BK190439 | 0 |