510(k) K952183 ยท JZO System, Test, Thyroid Autoantibody
DIASTAT ANTI-THYROGLOBULIN KIT
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Jun 30, 1995 |
| Received | May 9, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952183
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2005 | Diasorin Inc. Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700) Terminated |
JZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.