FREELITE HUMAN KAPPA AND LAMBDA KITS


Device Classification Name

kappa, antigen, antiserum, control

510(k) Number K040009
Device Name FREELITE HUMAN KAPPA AND LAMBDA KITS
Applicant
THE BINDING SITE, LTD.
west tower, suite 4000
2425 west olympic boulevard
santa monica, 
CA 
90404

Applicant Contact jay h geller
Correspondent
THE BINDING SITE, LTD.
west tower, suite 4000
2425 west olympic boulevard
santa monica, 
CA 
90404

Correspodent Contact jay h geller
Regulation Number 866.5550
Classification Product Code
DFH  
Subsequent Product Code
DEH  
Date Received 01/02/2004
Decision Date 03/11/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No