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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, Opiates
510(k) Number K902924
Device Name BIOSITE DIAGNOSTICS OPIATE SCREENING TEST
Applicant
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Applicant Contact KIM BLICKENSTAFF
Correspondent
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Correspondent Contact KIM BLICKENSTAFF
Regulation Number862.3650
Classification Product Code
DJG  
Date Received07/02/1990
Decision Date 09/14/1990
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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