The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Test, Donor, Cmv.
| Device ID | BK940035 |
| 510k Number | BK940035 |
| Device Name: | Test, Donor, CMV |
| Classification | Test, Donor, Cmv |
| Applicant | Hemagen Diagnostics, Inc. 9033 Red Branch Road Columbia, MD 21045 |
| 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 | 1994-06-23 |
| Decision Date | 1996-07-15 |