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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK220685
Test Name Qingdao HIGHTOP Biotech Co., Hightop Multi-Drug Urine Test Cup  
Manufacturer NameQingdao Hightop Biotech Co., Ltd.
Consumer Information Phone Number(800)319-8684
Test TypePhencyclidine (PCP)
Effective Date09/15/2022
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K220685
Device Name HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
Applicant
Qingdao Hightop Biotech Co., Ltd.
#369 Hedong Rd., Hi-Tech Industrial Development Zone
Qingdao,  CN 266112
Applicant Contact Ray Li
Correspondent
Lsi International
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
LCM   NFV   NFW   NFY   NGG  
NGL   PTG   PTH   QAW   QBF  
Date Received03/08/2022
Decision Date 05/05/2022
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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