510(k) K010050 ยท CGN Acid, Folic, Radioimmunoassay
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
| Applicant | Bayer Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Feb 5, 2001 |
| Received | Jan 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010050
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2023 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Siemens Material Number (SMN): 10310308 Open, Classified |
JJX | None listed |
| Feb 21, 2023 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Siemens Material Number (SMN): 10325366 Open, Classified |
JJX | None listed |
| Feb 21, 2023 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Siemens Material Number (SMN): 10331250
Siem Open, Classified |
JJX | None listed |
| Jan 21, 2020 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells
SMN:10310308 Terminated |
CGN | None listed |
| Jan 21, 2020 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells
SMN: 10325366 Terminated |
CGN | None listed |
| Jan 21, 2020 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell
SMN: 10331250 Terminated |
CGN | None listed |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Folate (FOL) Terminated |
CGN | None listed |
| Sep 4, 2015 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877.
Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay. Terminated |
CGN | None listed |
| May 7, 2014 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Folate
Cat No. 06891541 SMN 10325366 (500 tests)
Cat No. 06367974 SMN 10310308 (100 tests)
Cat No. 00203473 SMN 10331250 (Ref) (500 tests)
Cat No. 09132781 SMN 10340209 (Ref) (2 Terminated |
CGN | None listed |
| Sep 10, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974
In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. Terminated |
CGN | None listed |
| Sep 10, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541
In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. Terminated |
CGN | None listed |
| Sep 10, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473
In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. Terminated |
CGN | None listed |
| Sep 10, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781
In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. Terminated |
CGN | None listed |
| Dec 11, 2012 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare ADVIA Centaur Folate (FOL)
500 Test 06891541
100 Test 06367974
Ref Kit (US only) 09132781
Ref Kit (US only) 00203473
Intended Use For in vitro diagnostic Terminated |
CGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.