The following data is part of a premarket notification filed by Behring Diagnostics with the FDA for Cmv Tests For Donors.
| Device ID | BK960001 |
| 510k Number | BK960001 |
| Device Name: | CMV Tests For Donors |
| Classification | Test, Donor, Cmv |
| Applicant | Behring Diagnostics 175 University Avenue Westwood, MA 02090 US |
| Product Code | MZE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-10-09 |