510(k) K070057 ยท CGA Glucose Oxidase, Glucose
EASYRA CLINICAL CHEMISTRY ANALYZER
| Applicant | Medica Corp., Bedford MA, US |
| Decision | Substantially Equivalent, Aug 30, 2007 |
| Received | Jan 5, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070057
| 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.