510(k) K023894 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
ST AIA-PACK AFP ENZYME IMMUNOASSAY
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Dec 17, 2002 |
| Received | Nov 22, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023894
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK AFP; Part Number: 025252
Assay, Tumor Marker Terminated |
LOJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.