DIMENSION VISA HBA1C, MODEL K3105A— 510(k) K102045
Substantially EquivalentSiemens Heatlhcare Diagnostics, Inc.
FDA 510(k) clearance K102045 for DIMENSION VISA HBA1C, MODEL K3105A, Substantially Equivalent on 2011-02-14. Applicant: Siemens Heatlhcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Heatlhcare Diagnostics, Inc.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code LCP
view allMore clearances from Siemens Heatlhcare Diagnostics, Inc.
view allRecalls naming K102045
K-number listed on FDA's recall record- Z-0420-2015 — Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
- Z-0127-2015 — Dimension Vista¿ HbA1c
- Z-0626-2014 — HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102045.
Data sourced from openFDA. This site is unofficial and independent of the FDA.