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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 K060791
Device Name TRIAGE TOX DRUG SCREEN, MODEL 94400
Applicant
Biosite Incorporated
9975 Summers Ridge Rd.
San Deigo,  CA  92121
Applicant Contact Robin Weiner
Correspondent
Biosite Incorporated
9975 Summers Ridge Rd.
San Deigo,  CA  92121
Correspondent Contact Robin Weiner
Regulation Number862.3620
Classification Product Code
DJR  
Date Received03/23/2006
Decision Date 06/22/2006
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
Recalls CDRH Recalls
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