510(k) K182521 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
FastPack IP Sex Hormone Binding Globulin Immunoassay
| Applicant | Qualigen, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jan 29, 2019 |
| Received | Sep 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182521
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2025 | Qualigen Inc The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks. Open, Classified |
CDZ | None listed |
| Nov 6, 2019 | Qualigen Inc The FastPack System Comlete Immunoassay Kit
Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding G Terminated |
CDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.