DIMENSION VISA HBA1C, MODEL K3105A
FDA 510(k) clearance K102045 · decided 2011-02-14
Clearance details
- K-number
- K102045
- Device name
- DIMENSION VISA HBA1C, MODEL K3105A
- Applicant
- Siemens Heatlhcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-21
- Decision date
- 2011-02-14
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagen recall (Z-0420-2015) | Siemens Healthcare Diagnostics, Inc. | 2014-11-21 |
| Dimension Vista HbA1c recall (Z-0127-2015) | Siemens Healthcare Diagnostics, Inc. | 2014-10-24 |
| HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimensi recall (Z-0626-2014) | Siemens Healthcare Diagnostics, Inc. | 2014-01-03 |