The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Cmv Tests For Donors.
| Device ID | BK180247 |
| 510k Number | BK180247 |
| Device Name: | CMV Tests For Donors |
| Classification | Test, Donor, Cmv |
| Applicant | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 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 | 2018-08-23 |
| Decision Date | 2018-11-20 |