Innovita Flu A/B Antigen Rapid Test— 510(k) K250398

Name: FDA 510(k) clearance K250398
Creator: U.S. Food and Drug Administration
Published: 2025-07-03

Substantially Equivalent

Innovita (Tangshan) Biological Technology Co., Ltd.

FDA 510(k) clearance K250398 for Innovita Flu A/B Antigen Rapid Test, Substantially Equivalent on 2025-07-03. Applicant: Innovita (Tangshan) Biological Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Innovita (Tangshan) Biological Technology Co., Ltd.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2025-02-12
Decision date: 2025-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qian'An, CN

Download summary PDF View on FDA.gov ↗

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