INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS— 510(k) K081732
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K081732 for INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS, Substantially Equivalent on 2008-10-24. 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.