510(k) K003291 ยท JZO System, Test, Thyroid Autoantibody
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
| Applicant | Bayer Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Dec 5, 2000 |
| Received | Oct 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003291
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2024 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test) Open, Classified |
JZO | None listed |
| Sep 27, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test) Open, Classified |
JZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.