OLYMPUS FERRITIN REAGENT


Device Classification Name

ferritin, antigen, antiserum, control

510(k) Number K030124
Device Name OLYMPUS FERRITIN REAGENT
Original Applicant
OLYMPUS AMERICA, INC.
3131 west royal ln.
irving, 
TX 
75063 -3104

Original Contact michael campbell
Regulation Number 866.5340
Classification Product Code
DBF  
Date Received 01/14/2003
Decision Date 02/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No