IMMUNOCAP ALLERGEN K82


Device Classification Name

system, test, radioallergosorbent (rast) immunological

510(k) Number K121463
Device Name IMMUNOCAP ALLERGEN K82
Applicant
Thermo Fisher Scientific
4169 commercial avenue
portage, 
MI 
49002

Applicant Contact martin mann
Correspondent
Thermo Fisher Scientific
4169 commercial avenue
portage, 
MI 
49002

Correspodent Contact martin mann
Regulation Number 866.5750
Classification Product Code
DHB  
Date Received 05/17/2012
Decision Date 01/29/2013
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