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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Methamphetamine
510(k) Number K180878
Device Name BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx
Applicant
Shanghai Venture Bio-Tech Co., Ltd.
Rm. 313, Bldg. 2, # 2715 Longwu Rd., Xuhui District
Shanghai,  CN 200231
Applicant Contact Longli Long
Correspondent
Shanghai Thinkwell Consulting Co., Ltd.
Floor 6, #211, Xin Ling Rd., Minhang District
Shanghai,  CN 201100
Correspondent Contact Ethan Liu
Regulation Number862.3610
Classification Product Code
DJC  
Subsequent Product Codes
DIO   DKZ   DNK   JXM   LDJ  
NFT   NFV   NFW   NFY   NGG   NGI  
Date Received04/03/2018
Decision Date 12/17/2018
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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