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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Covid-19 Antigen Test
510(k) Number K241915
Device Name CareSuperb™ COVID-19 Antigen Home Test
Applicant
Access Bio, Inc.
65 Clyde Rd., Suite A.
Somerset,  NJ  08873
Applicant Contact Sung Jang
Correspondent
Access Bio, Inc.
65 Clyde Rd., Suite A.
Somerset,  NJ  08873
Correspondent Contact Sung Jang
Classification Product Code
QYT  
Date Received07/01/2024
Decision Date 01/29/2025
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
Predetermined Change
Control Plan Authorized		 No
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