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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
510(k) Number K240280
Device Name Nano-Check™ RSV 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 Number866.3480
Classification Product Code
GQG  
Date Received02/01/2024
Decision Date 07/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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