510(k) K020349 ยท JZO System, Test, Thyroid Autoantibody
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, Scotland, GB |
| Decision | Substantially Equivalent, May 2, 2002 |
| Received | Feb 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020349
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.