RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2


Device Classification Name

urinalysis controls (assayed and unassayed)

510(k) Number K110846
Device Name RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
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
JJW  
Date Received 03/28/2011
Decision Date 09/30/2011
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