FREELITE HUMAN LAMBDA FREE KIT


Device Classification Name

lambda, antigen, antiserum, control

510(k) Number K023131
Device Name FREELITE HUMAN LAMBDA FREE KIT
Original Applicant
THE BINDING SITE, LTD.
west tower, suite 4000
2425 west olympic boulevard
santa monica, 
CA 
90404

Original Contact jay h geller
Regulation Number 866.5550
Classification Product Code
DEH  
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