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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, opiates
510(k) Number K120763
Model REF#: 0240B (SMALL KIT), 0241B (LARGE KIT), REF#: 0001, 0252B, 0243B, 0246B, 0248B, 0249B, REF#: 0242B, 0244B, 0245B, 02
Device Name LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
Original Applicant
LIN-ZHI INTERNATIONAL, INC.
670 almanor ave
sunnyvale,  CA  94085
Original Contact bernice lin
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DLJ   LAS  
Date Received03/13/2012
Decision Date 06/01/2012
Decision substantially equivalent (SE)
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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