RANDOX RX DAYTONA


Device Classification Name

glucose oxidase, glucose

510(k) Number K024014
Device Name RANDOX RX DAYTONA
Original Applicant
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, county antrim, 

GB

bt29 4qy

Original Contact lynne hamilton
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Codes
CEM   CGZ   JGS   JIX   JJF  
Date Received 12/04/2002
Decision Date 12/04/2003
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