RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K110534
Device Name RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
Applicant
RANDOX LABORATORIES LIMITED
55 diamond road crumlin
crumlin antrim, 

GB

bt29 4qy

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

GB

bt29 4qy

Correspodent Contact pauline armstrong
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 02/25/2011
Decision Date 01/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No