510(k) K223179 · CGA Glucose Oxidase, Glucose
Cholestech LDX System
| Applicant | Alere San Diego, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 20, 2023 |
| Received | Oct 11, 2022 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K223179
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.