ADVIA CHEMISTRY FERRITIN (FRT) METHOD— 510(k) K110736
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K110736 for ADVIA CHEMISTRY FERRITIN (FRT) METHOD, Substantially Equivalent on 2011-08-17. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code DBF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code DBF
view all- K193650 — LIAISON Ferritin
- K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
- K171642 — Atellica IM Ferritin Assay
- K133083 — DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
- K121232 — K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
More clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K110736
K-number listed on FDA's recall record- Z-0128-2015 — ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
- Z-0129-2015 — ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
- Z-0130-2015 — ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110736.
Data sourced from openFDA. This site is unofficial and independent of the FDA.