RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K112337
Device Name RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
Applicant
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, county antrim, 

GB

bt29 4qy

Applicant Contact pauline armstrong
Correspondent
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, county antrim, 

GB

bt29 4qy

Correspodent Contact pauline armstrong
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 08/15/2011
Decision Date 12/01/2011
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