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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 K062242
Device Name METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS
Applicant
Lin-Zhi International, Inc.
687 N. Pastoria Ave.
Synnyvale,  CA  94085
Applicant Contact MARIE LIN
Correspondent
Lin-Zhi International, Inc.
687 N. Pastoria Ave.
Synnyvale,  CA  94085
Correspondent Contact MARIE LIN
Regulation Number862.3610
Classification Product Code
LAF  
Subsequent Product Codes
DLJ   LAS  
Date Received08/02/2006
Decision Date 09/29/2006
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
Predetermined Change
Control Plan Authorized		 No
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