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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
Applicant
CHEMTRON BIOTECH, INC.
8370 juniper creek ln ste 1-2
san diego,  CA  92126
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 - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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