TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K072892
Device Name TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
Applicant
BIOSITE INCORPORATED
9975 summers ridge rd
san diego, 
CA 
92121

Applicant Contact fil v buenviaje
Correspondent
BIOSITE INCORPORATED
9975 summers ridge rd
san diego, 
CA 
92121

Correspodent Contact fil v buenviaje
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 10/10/2007
Decision Date 12/07/2007
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