RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K121746
Device Name RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
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
JJX  
Date Received 06/14/2012
Decision Date 07/11/2012
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