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FDA 510(k)

Nano-Check Influenza A+B Test

K-Number: K252283 · 2026-01-15

ApplicantNano-Ditech Corporation
Decision Date2026-01-15
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Nano-Check Influenza A+B Test is the device name listed in this FDA 510(k) record. The listed applicant is Nano-Ditech Corporation. It received FDA 510(k) clearance on 2026-01-15 under 510(k) number K252283. 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 Nano-Check Influenza A+B Test?

Nano-Check Influenza A+B Test is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is Nano-Ditech Corporation. The 510(k) number is K252283.

When did Nano-Check Influenza A+B Test receive FDA 510(k) clearance?

Nano-Check Influenza A+B Test received FDA 510(k) clearance on 2026-01-15, under 510(k) number K252283.

Who is the listed applicant for Nano-Check Influenza A+B Test?

The FDA 510(k) record lists Nano-Ditech Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nano-Check Influenza A+B Test?

The FDA product code for Nano-Check Influenza A+B Test is PSZ.

Other records listing Nano-Ditech Corporation 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.

K243561Nano-Check Influenza+COVID-19 Dual TestK240280Nano-Check™ RSV TestK231187Nano-Check™ COVID-19 Antigen 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.

K250398Innovita 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, LLCK191514CareStart Flu A&B PlusAccess Bio, Inc.

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.

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