TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL


Device Classification Name

test,natriuretic peptide

510(k) Number K030286
Device Name TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
Original Applicant
BIOSITE INCORPORATED
11030 roselle st.
san diego, 
CA 
92121

Original Contact jeffrey r dahlen
Regulation Number 862.1117
Classification Product Code
NBC  
Subsequent Product Codes
DDR   JHX   MMI  
Date Received 01/28/2003
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