510(k) K012777 ยท JZO System, Test, Thyroid Autoantibody
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Oct 22, 2001 |
| Received | Aug 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012777
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2018 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur aTG (100 test kit)
Siemens Material Number (SMN): 10492398 Terminated |
JZO | None listed |
| Dec 7, 2018 | Siemens Healthcare Diagnostics, Inc SiemensADVIA Centaur aTG (500 test kit)
Siemens Material Number (SMN): 10492399 Terminated |
JZO | None listed |
| Dec 7, 2018 | Siemens Healthcare Diagnostics, Inc Siemens Atellica IM aTG (100 test kit)
Siemens Material Number (SMN): 10995461 Terminated |
JZO | None listed |
| Dec 7, 2018 | Siemens Healthcare Diagnostics, Inc Atellica IM aTG (500 test kit)
Siemens Material Number (SMN): 10995462 Terminated |
JZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.