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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K060788
Device Name TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
Applicant
Biosite Incorporated
9975 Summers Ridge Rd.
San Diego,  CA  92121
Applicant Contact Robin Weiner
Correspondent
Biosite Incorporated
9975 Summers Ridge Rd.
San Diego,  CA  92121
Correspondent Contact Robin Weiner
Regulation Number862.3280
Classification Product Code
DIF  
Date Received03/23/2006
Decision Date 07/10/2006
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
Recalls CDRH Recalls
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