ABBOTT ARCHITECT LH CALIBRATORS


Device Classification Name

calibrator, secondary

510(k) Number K111023
Device Name ABBOTT ARCHITECT LH CALIBRATORS
Applicant
ABBOTT LABORATORIES
100 abbott park road
dept 9v6, ap5n-2
abbott park, 
IL 
60064

Applicant Contact john rizos
Correspondent
ABBOTT LABORATORIES
100 abbott park road
dept 9v6, ap5n-2
abbott park, 
IL 
60064

Correspodent Contact john rizos
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 04/13/2011
Decision Date 06/10/2011
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