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FDA 510(k)

Innovita Flu A/B Antigen Rapid Test

K-Number: K250398 · 2025-07-03

ApplicantInnovita (Tangshan) Biological Technology Co., Ltd.
Decision Date2025-07-03
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Innovita Flu A/B Antigen Rapid Test is a medical device manufactured by Innovita (Tangshan) Biological Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-03 under approval number K250398. 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 Innovita Flu A/B Antigen Rapid Test?

Innovita Flu A/B Antigen Rapid Test is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Innovita (Tangshan) Biological Technology Co., Ltd.. The 510(k) number is K250398.

When was Innovita Flu A/B Antigen Rapid Test approved by the FDA?

Innovita Flu A/B Antigen Rapid Test received FDA 510(k) clearance on 2025-07-03, under approval number K250398.

What company makes Innovita Flu A/B Antigen Rapid Test?

Innovita Flu A/B Antigen Rapid Test is manufactured by Innovita (Tangshan) Biological Technology Co., Ltd..

What is the FDA product code for Innovita Flu A/B Antigen Rapid Test?

The FDA product code for Innovita Flu A/B Antigen Rapid Test is PSZ.

Other Devices by Innovita (Tangshan) Biological Technology Co., Ltd.

K192843INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream K241919Innovita HCG Pregnancy Rapid Combo Test

Related Devices (Code: PSZ)

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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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