510(k) K053131 ยท JFM Enzymatic Method, Bilirubin
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Dec 30, 2005 |
| Received | Nov 8, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053131
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin
SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitativ Terminated |
JFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.