IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR


Device Classification Name

igm, antigen, antiserum, control

510(k) Number K955797
Device Name IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
Applicant
RANDOX LABORATORIES, LTD.
ardmore, diamond road
crumlin, 

IE

bt29 4qy

Applicant Contact julie taylor
Correspondent
RANDOX LABORATORIES, LTD.
ardmore, diamond road
crumlin, 

IE

bt29 4qy

Correspodent Contact julie taylor
Regulation Number 866.5550
Classification Product Code
DFT  
Date Received 12/22/1995
Decision Date 04/05/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No