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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gas chromatography, methamphetamine
510(k) Number K113661
Device Name LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
Original Applicant
Lin-Zhi International, Inc.
670 almanor ave
sunnyvale,  CA  94085
Original Contact bernice lin
Regulation Number862.3610
Classification Product Code
LAF  
Subsequent Product Codes
DLJ   LAS  
Date Received12/13/2011
Decision Date 01/23/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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