510(k) K221119 ยท DCN System, Test, C-Reactive Protein
RCRP Flex reagent cartridge
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 17, 2023 |
| Received | Apr 18, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221119
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Revised C-Reactive Protein (RCRP);
Siemens Material Number (SMN): 11537223; Open, Classified |
DCN | None listed |
| Apr 10, 2025 | Siemens Healthcare Diagnostics, Inc. Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. Open, Classified |
DCN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.