510(k) K093939 ยท DKJ Colorimetry, Salicylate
ADVIA CHEMISTRY SALICYLATE REAGENT
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, May 19, 2010 |
| Received | Dec 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093939
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics) Terminated |
DKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.