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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 K153192
Device Name Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
Applicant
Chemtron Biotech, Inc.
9245 Brown Deer Rd.
San Diego,  CA  92121
Applicant Contact Jane Zhang
Correspondent
Chemtron Biotech, Inc.
9245 Brown Deer Rd.
San Diego,  CA  92121
Correspondent Contact Jane Zhang
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DIS   DJC   DJR   DKZ  
DNK   JXM   JXN   LAF   LCM   LDJ  
LFG  
Date Received11/03/2015
Decision Date 04/18/2016
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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