STRATUS CS ACUTE CARE D-DIMER— 510(k) K110303
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K110303 for STRATUS CS ACUTE CARE D-DIMER, Substantially Equivalent on 2011-05-16. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code DAP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code DAP
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Recalls naming K110303
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110303.
Data sourced from openFDA. This site is unofficial and independent of the FDA.