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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 K120761
Model REF#: 0330 (SMALL KIT), 0331 (LARGE KIT), REF#: 0001, 0332, 0333, 0334, 0335, REF#: 0337, 0338
Device Name LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 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 05/08/2012
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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