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
- Product 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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- K252283 — Nano-Check Influenza A+B Test
- K250398 — Innovita Flu A/B Antigen Rapid Test
- K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit
- K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
More clearances from SEKISUI Diagnostics, LLC
view all- K192719 — Osom Ultra Plus Flu A&B Test Kit
- K182001 — Acucy Influenza A&B Test with the Acucy System
- K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
- K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
- K123182 — OSOM INFLUENZA A&B TEST MODEL 190
Data sourced from openFDA. This site is unofficial and independent of the FDA.