Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Acucy Influenza A&B Test with the Acucy System

K-Number: K182001 · 2018-12-17

ApplicantSEKISUI Diagnostics, LLC
Decision Date2018-12-17
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Acucy Influenza A&B Test with the Acucy System is the device name listed in this FDA 510(k) record. The listed applicant is SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2018-12-17 under 510(k) number K182001. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acucy Influenza A&B Test with the Acucy System?

Acucy Influenza A&B Test with the Acucy System is a medical device that received FDA 510(k) clearance on 2018-12-17. The listed applicant is SEKISUI Diagnostics, LLC. The 510(k) number is K182001.

When did Acucy Influenza A&B Test with the Acucy System receive FDA 510(k) clearance?

Acucy Influenza A&B Test with the Acucy System received FDA 510(k) clearance on 2018-12-17, under 510(k) number K182001.

Who is the listed applicant for Acucy Influenza A&B Test with the Acucy System?

The FDA 510(k) record lists SEKISUI Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acucy Influenza A&B Test with the Acucy System?

The FDA product code for Acucy Influenza A&B Test with the Acucy System is PSZ.

Other records listing SEKISUI Diagnostics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemK192719Osom Ultra Plus Flu A&B Test KitK181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

Related Devices (Code: PSZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252283Nano-Check Influenza A+B TestNano-Ditech CorporationK250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLCK232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBdK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBdK192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑