The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Diastat Anti-thyroid Peroxidase Kit.
| Device ID | K951487 |
| 510k Number | K951487 |
| Device Name: | DIASTAT ANTI-THYROID PEROXIDASE KIT |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Contact | Peer Foster |
| Correspondent | Peer Foster SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-31 |
| Decision Date | 1995-06-30 |