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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name simple point-of-care device to directly detect sars-cov-2 viral targets from clinical specimens in near-patient settings
510(k) Number K231187
Device Name Nano-Check™ COVID-19 Antigen 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 Number866.3982
Classification Product Code
QVF  
Date Received04/26/2023
Decision Date 01/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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