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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, natriuretic peptide
510(k) Number K051787
Device Name TRIAGE BNP TEST, MODEL 98000XR
Applicant
BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO,  CA  92121
Applicant Contact JEFFREY DAHLEN
Correspondent
BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO,  CA  92121
Correspondent Contact JEFFREY DAHLEN
Regulation Number862.1117
Classification Product Code
NBC  
Date Received07/01/2005
Decision Date 09/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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