The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Diastat Anti-glomerular Basement Membrane Kit.
| Device ID | K963525 |
| 510k Number | K963525 |
| Device Name: | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| 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 | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-04 |
| Decision Date | 1996-11-07 |