The following data is part of a premarket notification filed by Gen-probe Gti Diagnostics with the FDA for Qualitative Test For Hla, Non-diagnostic.
| Device ID | BK110011 |
| 510k Number | BK110011 |
| Device Name: | Qualitative Test For HLA, Non-diagnostic |
| Classification | Test, Qualitative, For Hla, Non-diagnostic |
| Applicant | Gen-Probe GTI Diagnostics 20925 Crossroads Circle Waukesha, WI 53186 US |
| 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 | 2011-03-10 |
| Decision Date | 2012-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234400622 | BK110011 | 0 |
| 10888234400615 | BK110011 | 0 |
| 10888234400301 | BK110011 | 0 |