RANDOX C-REACTIVE PROTEIN


codes

Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K001009
Device Name RANDOX C-REACTIVE PROTEIN
Original Applicant
RANDOX LABORATORIES, LTD.
ardmore, 55 diamond road
crumlin, co. antrim, 

GB

bt29 4qy

Original Contact p. armstrong
Regulation Number 866.5270
Classification Product Code
DCK  
Date Received 03/29/2000
Decision Date 08/04/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls