510(k) K143075 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
| Applicant | Tosoh Bioscience, Inc., South San Franciso CA, US |
| Decision | Substantially Equivalent, Jul 2, 2015 |
| Received | Oct 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143075
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK SHBG; Part Number: 025238
Assay, Reproductive Hormone Terminated |
CDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.