The following data is part of a premarket notification filed by Centocor, Inc. with the FDA for Cmv Tests For Donors.
| Device ID | BK950010 |
| 510k Number | BK950010 |
| Device Name: | CMV Tests For Donors |
| Classification | Test, Donor, Cmv |
| Applicant | Centocor, Inc. 200 Great Valley Parkway Malvern, PA 19355 |
| 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 | 1994-12-28 |
| Decision Date | 1995-03-22 |