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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 K030286
Device Name TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
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 Number862.1117
Classification Product Code
NBC  
Subsequent Product Codes
DDR   JHX   MMI  
Date Received01/28/2003
Decision Date 02/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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