510(k) K010796 ยท MOI System, Test, Immunological, Antigen, Tumor
AIA-PACK BRCA, ST AIA PACK BRCA
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Aug 16, 2001 |
| Received | Mar 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK 27.29; Part Number: 025202
Assay, Tumor Marker Terminated |
MOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.