510(k) K023091 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
ST AIA-PACK TESTOSTERONE ASSAY
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Dec 17, 2002 |
| Received | Sep 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023091
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2026 | Tosoh Bioscience Inc ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204 Open, Classified |
CDZ | None listed |
| Nov 30, 2018 | Tosoh Bioscience Inc ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testo Terminated |
CDZ | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Testosterone; Part Number: 025204
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.