Acucy Influenza A&B Test with the Acucy System— 510(k) K182001

Name: FDA 510(k) clearance K182001
Creator: U.S. Food and Drug Administration
Published: 2018-12-17

Substantially Equivalent

SEKISUI 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. 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: 2018-07-26
Decision date: 2018-12-17
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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