510(k) K234091 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
| Applicant | Genalyte, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 22, 2024 |
| Received | Dec 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234091
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.