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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, Cannabinoids
510(k) Number K931598
Device Name BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)
Applicant
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Applicant Contact BRUNI, PH.D.
Correspondent
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Correspondent Contact BRUNI, PH.D.
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received04/01/1993
Decision Date 05/12/1993
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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