INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls— 510(k) K162540
Substantially EquivalentSiemens Healthcare Diagnostics Prodcts GmbH
FDA 510(k) clearance K162540 for INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls, Substantially Equivalent on 2017-08-22. Applicant: Siemens Healthcare Diagnostics Prodcts GmbH.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics Prodcts GmbH
- Product code
- Code KFF
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marburg, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.