510(k) K081875 ยท NDY Test, Cystatin C
GENTIAN CYSTATIN C IMMUNOASSAY
| Applicant | Gentian AS, San Diego CA, US |
| Decision | Substantially Equivalent, Aug 20, 2008 |
| Received | Jul 2, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2020 | Gentian AS GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models:
1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092
2. Gentian C E Calibrator Kit, 6 x 1 mL, Terminated |
NDY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.