510(k) K122766 ยท OUF Everolimus Immunoassay
THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
| Applicant | Microgenics Corp., Fremont Blvd. CA, US |
| Decision | Substantially Equivalent, Aug 20, 2013 |
| Received | Sep 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122766
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 3, 2016 | Microgenics Corporation Thermo Scientific QMS Everolimus Assay;
Model number:
0380000 (US Distribution);
0373852 (Foreign Distribution)
Product Usage:
The QMS Everolimus Assay is intended for the quantitative determination Terminated |
OUF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.