510(k) K011068— RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
Substantially EquivalentRhigene, Inc.
Clearance details
- Applicant
- Rhigene, Inc.
- Product code
- Code KTL
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.