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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K242498
Device Name Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC
Applicant
Aicheck Biotech, Inc.
17701 Cowan Suite 230
Irvine,  CA  92614
Applicant Contact Lisa Liu
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Dylan Wu
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
NFV   NFW   NFY   NGG   NGL  
NGM   PTG   PTH   QAW  
Date Received08/22/2024
Decision Date 10/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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