Atellica IM Folate Assay— 510(k) K172201
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K172201 for Atellica IM Folate Assay, Substantially Equivalent on 2018-04-12. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- 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
- Tarrytown, NY, US
Recent devices under product code CGN
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K172201
K-number listed on FDA's recall record- Z-1149-2023 — Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
- Z-1150-2023 — Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
- Z-1151-2023 — Atellica IM Folate 700 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): 11206252
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172201.
Data sourced from openFDA. This site is unofficial and independent of the FDA.