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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 K233358
Device Name SCoV-2 Ag Detect Rapid Test
Applicant
InBios International, Inc.
307 Westlake Ave. N, Suite 300
Seattle,  WA  98109
Applicant Contact Annabel Tsai
Correspondent
InBios International, Inc.
307 Westlake Ave. N, Suite 300
Seattle,  WA  98109
Correspondent Contact Estela Raychaudhuri
Classification Product Code
QVF  
Date Received09/29/2023
Decision Date 08/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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