ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
FDA 510(k) clearance K091867 · decided 2010-01-14
Clearance details
- K-number
- K091867
- Device name
- ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2009-06-23
- Decision date
- 2010-01-14
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- CDZ
- Device class
- 1
- Regulation number
- 862.1680
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024) | Siemens Healthcare Diagnostics | 2025-10-17 |
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| Dimension FPSA Flex reagent cartridge (P020027/S041) | Siemens Healthcare Diagnostics | 2025-02-24 |
| Dimension TPSA Flex reagent cartridge (P000021/S046) | Siemens Healthcare Diagnostics | 2025-02-24 |