The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Plasminogen Assay.
| Device ID | K781478 |
| 510k Number | K781478 |
| Device Name: | PLASMINOGEN ASSAY |
| Classification | Plasminogen, Antigen, Antiserum, Control |
| Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DDX |
| CFR Regulation Number | 866.5715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-28 |
| Decision Date | 1978-11-15 |