The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Diastat Anti-pr3 (c-anca) Kit.
| Device ID | K942813 |
| 510k Number | K942813 |
| Device Name: | DIASTAT ANTI-PR3 (C-ANCA) KIT |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Contact | George Zajicek |
| Correspondent | George Zajicek SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-14 |
| Decision Date | 1995-03-06 |