510(k) K223162 · LDJ Enzyme Immunoassay, Cannabinoids
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
| Applicant | Healgen Scientific,, LLC, Bellaire TX, US |
| Decision | Substantially Equivalent, Mar 17, 2023 |
| Received | Oct 7, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223162
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.