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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name colorimetry, acetaminophen
510(k) Number K043242
Device Name TRIAGE TOX DRUG SCREEN
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 Number862.3030
Classification Product Code
LDP  
Subsequent Product Codes
DIS   DJG   DKZ   JXM   JXO  
LAF   LCM   LDJ   LFG  
Date Received11/23/2004
Decision Date 02/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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