The following data is part of a premarket notification filed by American Dade with the FDA for Von Willebrand Factor Antigen Screen.
| Device ID | K842537 |
| 510k Number | K842537 |
| Device Name: | VON WILLEBRAND FACTOR ANTIGEN SCREEN |
| Classification | Crystal Violet For Histology |
| Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ICF |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-28 |
| Decision Date | 1984-10-01 |