RANDOX TRANSFERRIN


codes

Device Classification Name

transferrin, antigen, antiserum, control

510(k) Number K002585
Device Name RANDOX TRANSFERRIN
Original Applicant
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, co. antrim, 

IE

bt29 4qy

Original Contact pauline armstrong
Regulation Number 866.5880
Classification Product Code
DDG  
Date Received 08/21/2000
Decision Date 02/05/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No