ADVIA CENTAUR VITAMIN D TOTAL ASSAY— 510(k) K110586
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K110586 for ADVIA CENTAUR VITAMIN D TOTAL ASSAY, Substantially Equivalent on 2011-10-14. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code MRG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1825
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code MRG
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K110586
K-number listed on FDA's recall record- Z-0397-2017 — Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
- Z-0398-2017 — Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
- Z-1655-2014 — ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
- Z-1656-2014 — ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
- Z-1657-2014 — ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
- Z-1658-2014 — ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110586.
Data sourced from openFDA. This site is unofficial and independent of the FDA.