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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, Methadone
510(k) Number K051058
Device Name METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
Applicant
Lin-Zhi International, Inc.
687 N. Pastoria Ave.
Synnyvale,  CA  94085
Applicant Contact CHENG-I LIN
Correspondent
Lin-Zhi International, Inc.
687 N. Pastoria Ave.
Synnyvale,  CA  94085
Correspondent Contact CHENG-I LIN
Regulation Number862.3620
Classification Product Code
DJR  
Subsequent Product Codes
DLJ   LAS  
Date Received04/26/2005
Decision Date 03/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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