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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 K013002
Device Name TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
Applicant
BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO,  CA  92121
Applicant Contact JEFFREY R DAHLEN
Correspondent
BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO,  CA  92121
Correspondent Contact JEFFREY R DAHLEN
Regulation Number862.3280
Classification Product Code
DIF  
Date Received09/06/2001
Decision Date 10/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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