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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 K031797
Device Name METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
Applicant
Lin-Zhi International, Inc.
687 N. Pastoria Ave.
Synnyvale,  CA  94085 -2917
Applicant Contact CHENG-I LIN
Correspondent
Lin-Zhi International, Inc.
687 N. Pastoria Ave.
Synnyvale,  CA  94085 -2917
Correspondent Contact CHENG-I LIN
Regulation Number862.3620
Classification Product Code
DJR  
Subsequent Product Code
DLJ  
Date Received06/10/2003
Decision Date 10/10/2003
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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