510(k) K243365 ยท NGL Test, Opiates, Over The Counter
Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
| Applicant | Healgen Scientific,, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Dec 17, 2024 |
| Received | Oct 29, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243365
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.