Acucy® Influenza A&B Test with the Acucy® 2 System— 510(k) K241188
Substantially EquivalentSEKISUI Diagnostics, LLC
FDA 510(k) clearance K241188 for Acucy® Influenza A&B Test with the Acucy® 2 System, Substantially Equivalent on 2025-04-18. Applicant: SEKISUI Diagnostics, LLC. Device class: 2.
Clearance details
- Applicant
- SEKISUI Diagnostics, LLC
- Product code
- Code PSZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3328
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- San Diego, CA, US
Recent devices under product code PSZ
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Data sourced from openFDA. This site is unofficial and independent of the FDA.