510(k) K170065 · JFM Enzymatic Method, Bilirubin
ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 9, 2017 |
| Received | Jan 9, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2023 | Siemens Healthcare Diagnostics, Inc. Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the
quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates
Test Code: TBil_2
Siemen Open, Classified |
JFM | None listed |
| Feb 13, 2020 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Total Bilirubin_2 assay-
SMN: 10341115 (40 mL) & 10341113 (70 mL).
Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in Terminated |
JFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.