The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Qualitative Test For Hla, Non-diagnostic.
| Device ID | BK050073 |
| 510k Number | BK050073 |
| Device Name: | Qualitative Test For HLA, Non-diagnostic |
| Classification | Test, Qualitative, For Hla, Non-diagnostic |
| Applicant | BD Biosciences 2350 Qume Drive San Jose, CA 95131 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 | 2005-11-28 |
| Decision Date | 2006-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903401833 | BK050073 | 000 |
| 00382906407764 | BK050073 | 000 |
| 00382906579874 | BK050073 | 000 |
| 00382906434388 | BK050073 | 000 |