K012755
Substantially EquivalentAUTODIMER ASSAY MODEL # 1431
- Applicant
- Xtrana, Inc.
- Product code
- DAP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ventura, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.