510(k) K151792 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Nov 20, 2015 |
| Received | Jul 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151792
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens.
Siemens Material Number (SMN): 11066001 Open, Classified |
JLW | None listed |
| Apr 13, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens
Siemens Material Number (SMN): 11066000 Open, Classified |
JLW | None listed |
| Sep 28, 2021 | Siemens Healthcare Diagnostics, Inc Atellica IM 1300 Analyzer, SMN 11066001 Open, Classified |
JJE | None listed |
| Sep 28, 2021 | Siemens Healthcare Diagnostics, Inc Atellica IM 1600 Analyzer, SMN 11066000 Open, Classified |
JJE | None listed |
| May 13, 2021 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens
SMN 11066001 Open, Classified |
JLW | None listed |
| May 13, 2021 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens
SMN 11066000 Open, Classified |
JLW | None listed |
| Dec 2, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis o Terminated |
JJE | None listed |
| Dec 2, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis o Terminated |
JJE | None listed |
| Oct 26, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 Terminated |
JLW | None listed |
| Oct 26, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens.
Siemens Material Number (SMN): 11066000 Terminated |
JLW | None listed |
| Jun 19, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960 Open, Classified |
JJE | None listed |
| Jun 19, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026 Open, Classified |
JJE | None listed |
| Aug 15, 2019 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2
Siemens Material Number (SMN): 11066001 Terminated |
JJE | None listed |
| Aug 15, 2019 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2
Siemens Material Number (SMN): 11066000 Terminated |
JJE | None listed |
| Mar 7, 2019 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer, Material Number 11066001 Terminated |
JLW | None listed |
| Mar 7, 2019 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer, Material Number 11066000 Terminated |
JLW | None listed |
| Sep 26, 2018 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro di Terminated |
JIT | None listed |
| Sep 26, 2018 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. Terminated |
JIT | None listed |
| Jun 29, 2018 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer (SMN 11066001).
The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. Terminated |
JJE | None listed |
| Jun 29, 2018 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer (SMN 11066000).
The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. Terminated |
JJE | None listed |
| Feb 26, 2018 | Siemens Healthcare Diagnostics, Inc. Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. Terminated |
JJE | None listed |
| Feb 26, 2018 | Siemens Healthcare Diagnostics, Inc. Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens. Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.