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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, Benzodiazepine
510(k) Number K123080
Device Name CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS
Applicant
Chemtron Biotech, Inc.
8370 Juniper Creek Ln.
Suite 1-2
San Diego,  CA  92126
Applicant Contact Jane Zhang
Correspondent
Chemtron Biotech, Inc.
8370 Juniper Creek Ln.
Suite 1-2
San Diego,  CA  92126
Correspondent Contact Jane Zhang
Regulation Number862.3170
Classification Product Code
JXM  
Subsequent Product Codes
DIS   DJC   DJG   DJR   DNK  
Date Received10/01/2012
Decision Date 11/29/2012
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
Predetermined Change
Control Plan Authorized		 No
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