510(k) K231045 ยท LJX Test, Urine Leukocyte
Healgen URS Test Strips
| Applicant | Healgen Scientific,, LLC, Bellaire TX, US |
| Decision | Substantially Equivalent, Jun 16, 2023 |
| Received | Apr 12, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231045
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.