HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS


Device Classification Name

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

510(k) Number K103824
Device Name HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
Applicant
THE BINDING SITE
po box 11712
birmingham, 

GB

b14 4zb

Applicant Contact suzanne horne
Correspondent
THE BINDING SITE
po box 11712
birmingham, 

GB

b14 4zb

Correspodent Contact suzanne horne
Regulation Number 866.5510
Classification Product Code
CFN  
Date Received 12/30/2010
Decision Date 02/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No