510(k) K031393 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
BAYER ADVIA CENTAUR CA 19-9 ASSAY
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 24, 2003 |
| Received | May 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SMN: 109954 Open, Classified |
NIG | None listed |
| Sep 11, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SMN:109 Open, Classified |
NIG | None listed |
| Sep 11, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SM Open, Classified |
NIG | None listed |
| Sep 11, 2024 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SMN: 1049 Open, Classified |
NIG | None listed |
| Sep 11, 2024 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SMN: 10 Open, Classified |
NIG | None listed |
| Oct 19, 2016 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.
Siemens Material Number(SMN): 10491379
In the 510(k) d Terminated |
NIG | None listed |
| Oct 19, 2016 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.
Siemens Material Number(SMN): 10491244
In the 510(k) d Terminated |
NIG | None listed |
| Dec 11, 2012 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare ADVIA Centaur CA 19-9
250 Test 10491244
50 Test 10491379
Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tu Terminated |
NIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.