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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
Models REF# 000, 0352,0353,0354, 03555, REF# 0357,03558, REF#; 0350 (SMAALL KIT), 0351 (LARGE KIT)
Device Name LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
Applicant
LIN-ZHI INTERNATIONAL, INC.
670 almanor ave
sunnyvale,  CA  94085
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 - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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