510(k) K071388 ยท NDY Test, Cystatin C
GENTIAN CYSTATIN C IMMUNOASSAY
| Applicant | Gentian AS, San Diego CA, US |
| Decision | Substantially Equivalent, Nov 6, 2007 |
| Received | May 18, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071388
| 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.