STRATUS CS ACUTE CARE D-DIMER
FDA 510(k) clearance K110303 · decided 2011-05-16
Clearance details
- K-number
- K110303
- Device name
- STRATUS CS ACUTE CARE D-DIMER
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2011-02-01
- Decision date
- 2011-05-16
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- DAP
- Device class
- 2
- Regulation number
- 864.7320
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic recall (Z-0611-2016) | Siemens Healthcare Diagnostics Inc | 2016-01-07 |
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