OLYMPUS IGM REAGENT


Device Classification Name

method, nephelometric, immunoglobulins (g, a, m)

510(k) Number K073487
Device Name OLYMPUS IGM REAGENT
Applicant
OLYMPUS AMERICA INC.
lismeehan, o, callaghan’s
mills
co. clare, 

IE

Applicant Contact stephanie g donnelly
Correspondent
OLYMPUS AMERICA INC.
lismeehan, o, callaghan’s
mills
co. clare, 

IE

Correspodent Contact stephanie g donnelly
Regulation Number 866.5510
Classification Product Code
CFN  
Date Received 12/12/2007
Decision Date 02/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No