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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, amphetamine
510(k) Number K063024
Device Name LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS
Applicant
Lin-Zhi International, Inc.
687 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2917
Applicant Contact MARIE LIN
Correspondent
Lin-Zhi International, Inc.
687 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2917
Correspondent Contact MARIE LIN
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DLJ   LAS  
Date Received10/02/2006
Decision Date 10/30/2006
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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