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Document NumberK140748
Test Name Tanner Scientific Multi-Panel Drug Test Cup  
Manufacturer NameCO-INNOVATION BIOTECH CO.,LTD.
Consumer Information Phone Number(800)331-2716
Test TypeEDDP (methadone metabolite)
Effective Date03/08/2016
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.
No.13, Yanyuan Road, Tianhe District,
Guangzhou,  CN 510507
Applicant Contact HONG FENG
Correspondent
CO-INNOVATION BIOTECH CO.,LTD.
No.13, Yanyuan Road, Tianhe District,
Guangzhou,  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
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