510(k) K141999 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
ADVIA CENTAUR TSH
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Apr 22, 2015 |
| Received | Jul 23, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141999
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2017 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the follow Terminated |
JJE | None listed |
| May 26, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979).
Terminated |
JLW | None listed |
| Apr 28, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur XPT Immunoassay System Terminated |
JLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.