510(k) K072249 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT
| Applicant | Medica Corp., Beverly MA, US |
| Decision | Substantially Equivalent, Feb 20, 2008 |
| Received | Aug 13, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072249
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2010 | Medica Corporation EasyRA Cuvette Segment 1, P/N 007000-001
(In Vitro Diagnostic )
EasyRA Cuvette Segments included in the following Kits:
EasyRA Cuvettes, REF 10700-4
Startup Kit - Chemistry, REF 10990
Startup Kit - C Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.