TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K030089
Device Name TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS
Original Applicant
BIOSITE INCORPORATED
11030 roselle st.
san diego, 
CA 
92121

Original Contact jeffrey r dahlen
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 01/10/2003
Decision Date 01/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No