510(k) K110830 ยท CIX Bromcresol Green Dye-Binding, Albumin
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
| Applicant | Elitechgroup, Bothell WA, US |
| Decision | Substantially Equivalent, Jun 21, 2011 |
| Received | Mar 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110830
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2013 | SEPPIM SAS Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum.
The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL.
The vial's label shows CALCIUM ARSEN Terminated |
CJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.