510(k) K110616 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
| Applicant | Microgenics Corp., Fremont Blvd. CA, US |
| Decision | Substantially Equivalent, Jun 29, 2011 |
| Received | Mar 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110616
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2014 | Microgenics Corporation MAS Omni Immune Controls Terminated |
JJY | None listed |
| Jun 26, 2014 | Microgenics Corporation MAS Omni Immune PRO Controls Terminated |
JJY | None listed |
| Nov 19, 2012 | Microgenics Corporation Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO;
Liquid Assayed Integrated Immunoassay Control.
Intended for use as an assayed control for monitoring assay conditions in many clinical laborator Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.