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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K140748
Device Name ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
Applicant
Co-Innovation Biotech Co., Ltd.
# 13 Yanyuan Rd.. Tianhe District
Guangzhou, Guangdong,  CN 510507
Applicant Contact HONG FENG
Correspondent
Co-Innovation Biotech Co., Ltd.
# 13 Yanyuan Rd.. Tianhe District
Guangzhou, Guangdong,  CN 510507
Correspondent Contact HONG FENG
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DJR   DNK   JXN   LFG  
Date Received03/25/2014
Decision Date 08/20/2014
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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