RANDOX LIPID CONTROL


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K022591
Device Name RANDOX LIPID CONTROL
Original Applicant
RANDOX LABORATORIES, LTD.
ardmore, diamond road
crumlin, co. antrim, 

GB

bt29 4qy

Original Contact pauline armstrong
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 08/05/2002
Decision Date 08/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No