510(k) K061196 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
CARDIOIMMUNE XL CARDIAC MARKER CONTROL
| Applicant | Microgenics Corp., Fremont Blvd. CA, US |
| Decision | Substantially Equivalent, May 30, 2006 |
| Received | Apr 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061196
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2014 | Microgenics Corporation MAS CardioImmune XL Cardiac Marker Control;
Model: CAI-XL1;
intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determin Terminated |
JJY | None listed |
| Jan 11, 2012 | Microgenics Corporation ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic.
Catalog Numbers & Description:
CAI-XLL, Level L; CAI-XL1, Level 1; CAI-X Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.