510(k) K161954 ยท JGS Electrode, Ion Specific, Sodium
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 9, 2017 |
| Received | Jul 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161954
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2024 | Siemens Healthcare Diagnostics, Inc. Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step.
Siemens Material Number(SMN): 11099326
A Open, Classified |
JJE | None listed |
| Mar 2, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 Open, Classified |
JGS | None listed |
| Mar 7, 2019 | Siemens Healthcare Diagnostics, Inc. Atellica Sample Handler Prime, Material Number 11069001 Terminated |
JGS | None listed |
| Sep 26, 2018 | Siemens Healthcare Diagnostics, Inc. Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in v Terminated |
JIT | None listed |
| Jun 29, 2018 | Siemens Healthcare Diagnostics, Inc. Atellica Sample Handler Prime (SMN 11069001).
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 Sample Handler Connect (SMN 11069018).
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 Sample Handler Additional (SMN 11069004).
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. Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens. Terminated |
JGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.