DIRECT LDL/HDL CHOLESTEROL CALIBRATOR


Device Classification Name

calibrator, primary

510(k) Number K122126
Device Name DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
Applicant
RANDOX LABORATORIES LIMITED
34 diamond road
crumlin antrim, 

GA

bt29 4qy

Applicant Contact pauline armstrong
Correspondent
RANDOX LABORATORIES LIMITED
34 diamond road
crumlin antrim, 

GA

bt29 4qy

Correspodent Contact pauline armstrong
Regulation Number 862.1150
Classification Product Code
JIS  
Date Received 07/18/2012
Decision Date 08/14/2012
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