510(k) K122126 ยท JIS Calibrator, Primary
DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
| Applicant | Randox Laboratories Limited, Crumlin, County Antrim, GA |
| Decision | Substantially Equivalent, Aug 14, 2012 |
| Received | Jul 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122126
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.