ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY— 510(k) K010050
Substantially EquivalentBayer Diagnostics Corp.
FDA 510(k) clearance K010050 for ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY, Substantially Equivalent on 2001-02-05. Applicant: Bayer Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Diagnostics Corp.
- Product code
- Code CGN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1295
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
Recent devices under product code CGN
view allMore clearances from Bayer Diagnostics Corp.
view allRecalls naming K010050
K-number listed on FDA's recall record- Z-1152-2023 — 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
- Z-1153-2023 — 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
- Z-1154-2023 — 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 Siemens Material Number (SMN): 10325366
- Z-0829-2020 — Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
- Z-0830-2020 — Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
- Z-0831-2020 — Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
- Z-1689-2018 — ADVIA Centaur¿ Folate (FOL)
- Z-2739-2015 — 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.
- Z-1564-2014 — 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) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems
- Z-2169-2013 — 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.
- Z-2170-2013 — 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.
- Z-2171-2013 — 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.
- Z-2172-2013 — 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.
- Z-0511-2013 — 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 use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010050.
Data sourced from openFDA. This site is unofficial and independent of the FDA.