Acucy Influenza A&B Test with the Acucy System— 510(k) K182001
Substantially EquivalentSEKISUI Diagnostics, LLC
FDA 510(k) clearance K182001 for Acucy Influenza A&B Test with the Acucy System, Substantially Equivalent on 2018-12-17. Applicant: SEKISUI Diagnostics, LLC.
Clearance details
- Applicant
- SEKISUI Diagnostics, LLC
- Product code
- Code PSZ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- San Diego, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.