K812646
Substantially EquivalentSKI 5000
- Applicant
- Smithkline Diagnostics, Inc.
- Product code
- DXK
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.