510(k) K023240 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
ST AIA-PACK CA 19-9
| Applicant | Tosoh Corp., Seymour CT, US |
| Decision | Substantially Equivalent, Dec 23, 2002 |
| Received | Sep 27, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023240
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK CA 19-9; Part Number: 025271
Assay, Tumor Marker Terminated |
NIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.