FREELITE KAPPA FREE KIT


Device Classification Name

lambda, antigen, antiserum, control

510(k) Number K010441
Device Name FREELITE KAPPA 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 02/13/2001
Decision Date 04/26/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized