The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Abbott Axsym Anti-thyroid-peroxidase, Models5f57 Comprising Standards/calibrators.
| Device ID | K020348 |
| 510k Number | K020348 |
| Device Name: | ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE Dundee, Scotland, GB Dd2 1xa |
| Contact | Eileen A Mccafferty |
| Correspondent | Eileen A Mccafferty AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE Dundee, Scotland, GB Dd2 1xa |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-04 |
| Decision Date | 2002-05-02 |