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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK242077
Test Name Aicheck Biotech, Inc., Pocguide Multi-Drug Test Cup OTC  
Manufacturer NameAicheck Biotech, Inc.
Consumer Information Phone Number1(888)551-5686
Test TypeEDDP (methadone metabolite)
Effective Date08/20/2024
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K242077
Device Name PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
Applicant
Aicheck Biotech, Inc.
17701 Cowan Suite 230
Irvine,  CA  92614
Applicant Contact Lisa Liu
Correspondent
LSI International, Inc.
504 E Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Jenny Xia
Regulation Number862.3100
Classification Product Code
NFT  
Date Received07/16/2024
Decision Date 08/14/2024
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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