INNOVANCE D-DIMER, MODEL OPBP09— 510(k) K091916
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K091916 for INNOVANCE D-DIMER, MODEL OPBP09, Substantially Equivalent on 2009-10-29. Applicant: Siemens Healthcare Diagnostics.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code DAP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.