TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS


Device Classification Name

test,natriuretic peptide

510(k) Number K080269
Device Name TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
Applicant
BIOSITE INCORPORATED
9975 summers ridge rd
san diego, 
CA 
92121

Applicant Contact dawn a allenby
Correspondent
BIOSITE INCORPORATED
9975 summers ridge rd
san diego, 
CA 
92121

Correspodent Contact dawn a allenby
Regulation Number 862.1117
Classification Product Code
NBC  
Subsequent Product Codes
DAP   DDR   JHX   MMI  
Date Received 02/01/2008
Decision Date 06/06/2008
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