510(k) K161494 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Nov 15, 2016 |
| Received | Jun 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161494
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Chemistry Calibrator Terminated |
CGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.