IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS


Device Classification Name

system, test, radioallergosorbent (rast) immunological

510(k) Number K111919
Device Name IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
Applicant
PHADIA US INC.
4169 commercial ave.
portage, 
MI 
49002

Applicant Contact martin mann
Correspondent
PHADIA US INC.
4169 commercial ave.
portage, 
MI 
49002

Correspodent Contact martin mann
Regulation Number 866.5750
Classification Product Code
DHB  
Date Received 07/07/2011
Decision Date 12/22/2011
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