510(k) K033038 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Dec 29, 2003 |
| Received | Sep 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2020 | Beckman Coulter Inc. Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems including:
Access 2, UniCel DxI 600, UniC Terminated |
NIG | None listed |
| May 9, 2017 | Beckman Coulter Inc. Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687 Terminated |
NIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.