The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Shield Helico-g2 Elisa Kit.
| Device ID | K972981 |
| 510k Number | K972981 |
| Device Name: | SHIELD HELICO-G2 ELISA KIT |
| Classification | Helicobacter Pylori |
| 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 | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-11 |
| Decision Date | 1998-03-17 |