510(k) K172201 ยท CGN Acid, Folic, Radioimmunoassay
Atellica IM Folate Assay
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Apr 12, 2018 |
| Received | Jul 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172201
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2023 | Siemens Healthcare Diagnostics, Inc. Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Siemens Material Number (SMN): 10995572 Open, Classified |
CGN | None listed |
| Feb 21, 2023 | Siemens Healthcare Diagnostics, Inc. Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Siemens Material Number (SMN): 10995573 Open, Classified |
CGN | None listed |
| Feb 21, 2023 | Siemens Healthcare Diagnostics, Inc. Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Siemens Material Number (SMN): 11206252 Open, Classified |
CGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.