FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER


Device Classification Name

kappa, antigen, antiserum, control

510(k) Number K023009
Device Name FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER
Original Applicant
THE BINDING SITE, LTD.
east tower, suite 600
2425 west olympic boulevard
santa monica, 
CA 
90404

Original Contact jay h geller
Regulation Number 866.5550
Classification Product Code
DFH  
Date Received 09/09/2002
Decision Date 01/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No