AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES


Device Classification Name

system, test, radioallergosorbent (rast) immunological

510(k) Number K121156
Device Name AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
Applicant
PHADIA AB
4169 commercial avenue
portage, 
MI 
49002

Applicant Contact martin mann
Correspondent
PHADIA AB
4169 commercial avenue
portage, 
MI 
49002

Correspodent Contact martin mann
Regulation Number 866.5750
Classification Product Code
DHB  
Date Received 04/16/2012
Decision Date 03/13/2013
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

Category: Uncategorized