K013549
Substantially EquivalentSIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- DAP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.