OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test— 510(k) K181436
Substantially EquivalentSEKISUI Diagnostics, LLC
FDA 510(k) clearance K181436 for OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test, Substantially Equivalent on 2018-06-22. Applicant: SEKISUI Diagnostics, LLC.
Clearance details
- Applicant
- SEKISUI Diagnostics, LLC
- Product code
- Code KTN
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.