The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Shield Von Willebrand Factor Activity Elisa, Model Fvwf 200.
| Device ID | K000398 |
| 510k Number | K000398 |
| Device Name: | SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Contact | Eileen Mccafferty |
| Correspondent | Eileen Mccafferty SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-04-17 |