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FDA 510(k)

Nano-Check Influenza A+B Test

K-Number: K252283 · 2026-01-15

Decision Date2026-01-15
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Nano-Check Influenza A+B Test is a medical device manufactured by Nano-Ditech Corporation. It received FDA 510(k) clearance on 2026-01-15 under approval 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. It is manufactured by Nano-Ditech Corporation. The 510(k) number is K252283.

When was Nano-Check Influenza A+B Test approved by the FDA?

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

What company makes Nano-Check Influenza A+B Test?

Nano-Check Influenza A+B Test is manufactured by Nano-Ditech Corporation.

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 Devices by Nano-Ditech Corporation

Related Devices (Code: PSZ)

Official Source

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