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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fibrin split products
510(k) Number K042890
Device Name TRIAGE D-DIMER TEST, MODEL 98100
Applicant
BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO,  CA  92121
Applicant Contact JEFFERY R DAHLEN
Correspondent
BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO,  CA  92121
Correspondent Contact JEFFERY R DAHLEN
Regulation Number864.7320
Classification Product Code
GHH  
Subsequent Product Code
DAP  
Date Received10/19/2004
Decision Date 11/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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