The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Diastat Anti-thyroglobulin Kit.
| Device ID | K952183 |
| 510k Number | K952183 |
| Device Name: | DIASTAT ANTI-THYROGLOBULIN KIT |
| Classification | System, Test, Thyroid Autoantibody |
| 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 | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-09 |
| Decision Date | 1995-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817016271 | K952183 | 000 |
| 07340058410110 | K952183 | 000 |