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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK221871
Test Name Healgen, Healgen Accurate Drug of Abuse Urine EZ Split Cup  
Manufacturer NameHealstone Biotech, Inc.
Consumer Information Phone Number1(866)982-3818
Test TypeMethamphetamines
Effective Date12/07/2022
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K221871
Device Name Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
Applicant
Healstone Biotech, Inc.
Unit 650 - 655 W. Kent Ave. N.
Vancouver,  CA V6P 6T7
Applicant Contact Bryan Fang
Correspondent
LSI International, Inc.
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
NFV   NFW   NFY   NGG   NGL  
NGM   PTG   PTH   QAW   QBF  
Date Received06/28/2022
Decision Date 08/30/2022
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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