K030328
Substantially EquivalentVIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
- Applicant
- bioMerieux, Inc.
- Product code
- DAP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.