RANDOX COMPLEMENT C4


the company

Device Classification Name

complement c4, antigen, antiserum, control

510(k) Number K000468
Device Name RANDOX COMPLEMENT C4
Original Applicant
RANDOX LABORATORIES, LTD.
ardmore, diamond road
crumlin, bt29 4qy co.
antrim, n. ireland, 

IR

Original Contact p armstrong
Regulation Number 866.5240
Classification Product Code
DBI  
Date Received 02/11/2000
Decision Date 03/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No