510(k) K083386 ยท CJY Azo Dye, Calcium
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Apr 2, 2009 |
| Received | Nov 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083386
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 Open, Classified |
CJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.