RANDOX APOLIPOPROTEIN CALIBRATOR


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K023158
Device Name RANDOX APOLIPOPROTEIN CALIBRATOR
Original Applicant
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, county antrim, 

GB

bt29 4qy

Original Contact pauline armstrong
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 09/23/2002
Decision Date 10/24/2002
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