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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K252283
Device Name Nano-Check Influenza A+B Test
Applicant
Nano-Ditech Corporation
259 Prospect Plains Rd., Bldg. K.
Cranbury,  NJ  08512
Applicant Contact James B Chang
Correspondent
Nano-Ditech Corporation
259 Prospect Plains Rd., Bldg. K.
Cranbury,  NJ  08512
Correspondent Contact James B Chang
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received07/22/2025
Decision Date 01/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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