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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK153646
Test Name Safecare Biotech (Hangzhou) Co., Ltd., TTestahead Cocaine (COC) Urine Test Dipcard  
Manufacturer NameSafecare Biotech (Hangzhou) Co., Ltd.
Consumer Information Phone Number1(800)319-8684
Test TypeCocaine metabolites
Effective Date06/20/2024
Device Classification Name Enzyme Immunoassay, Cocaine And Cocaine Metabolites
510(k) Number K153646
Device Name SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
Applicant
Safecare Biotech (Hangzhou) Co., Ltd.
Bldg. 2/203 #18 Haishu Rd., Cangqian Sub-District
Yuhang District
Hangzhou,  CN 311121
Applicant Contact Alex Qiu
Correspondent
Lsi International
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DKZ   LDJ  
Date Received12/21/2015
Decision Date 03/18/2016
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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