The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Shield Diastat Anti-b2 Glycoprotein 1 Igg (elisa) Assay.
| Device ID | K982879 |
| 510k Number | K982879 |
| Device Name: | SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Applicant | SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Contact | Eileen A Mccafferty |
| Correspondent | Eileen A Mccafferty SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-14 |
| Decision Date | 1998-10-15 |