The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Diastat Ena Single Well Screen Kit.
| Device ID | K944505 |
| 510k Number | K944505 |
| Device Name: | DIASTAT ENA SINGLE WELL SCREEN KIT |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Contact | Peter Foster |
| Correspondent | Peter Foster SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-14 |
| Decision Date | 1994-11-21 |