510(k) K053132 ยท JFM Enzymatic Method, Bilirubin
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
| 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 K053132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin
SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative deter Terminated |
JFM | None listed |
| Feb 13, 2020 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin i Terminated |
JFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.