510(k) K132031 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
| Applicant | Axis-Shield Poc AS, Oslo, NO |
| Decision | Substantially Equivalent, Mar 21, 2014 |
| Received | Jul 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132031
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.