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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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