510(k) K991576 ยท CIX Bromcresol Green Dye-Binding, Albumin
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 30, 1999 |
| Received | May 6, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative
determination of iron in human serum and (lithium heparin) plasma samples. Open, Classified |
JIY | None listed |
| Mar 27, 2018 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems Terminated |
CDQ | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated Terminated |
KNK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.