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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, amphetamine
510(k) Number K121339
Device Name CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS
Original Applicant
CHEMTRON BIOTECH, INC.
9245 brown deer rd
san diego,  CA  92121
Original Contact jane zhang
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJC   DNK   LCM   LDJ  
Date Received05/03/2012
Decision Date 05/17/2012
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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