510(k) K973819— VIDAS D-DIMER (DD) ASSAY
Substantially EquivalentBiomerieux Vitek, Inc.
Clearance details
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- Code DAP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockland, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.