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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
510(k) Number K934340
Device Name BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS
Applicant
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Applicant Contact JOHN F BRUNI
Correspondent
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Correspondent Contact JOHN F BRUNI
Regulation Number862.3910
Classification Product Code
LFI  
Date Received09/08/1993
Decision Date 12/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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