TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K030088
Device Name TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION 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 01/17/2003
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