ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
FDA 510(k) clearance K081895 · decided 2009-01-08
Clearance details
- K-number
- K081895
- Device name
- ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
- Applicant
- Siemens Medical Solutions Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2008-07-03
- Decision date
- 2009-01-08
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog recall (Z-2643-2014) | Siemens Healthcare Diagnostics | 2014-09-15 |
| ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADV recall (Z-2135-2013) | Siemens Healthcare Diagnostics | 2013-09-03 |