HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER


Device Classification Name

method, nephelometric, immunoglobulins (g, a, m)

510(k) Number K072889
Device Name HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
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 866.5510
Classification Product Code
CFN  
Date Received 10/10/2007
Decision Date 02/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No