ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY


Device Classification Name

system,test,antibodies,b2 – glycoprotein i (b2 – gpi)

510(k) Number K112414
Device Name ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
Applicant
PHADIA US INC.
4169 commercial ave.
portage, 
MI 
49002

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

Correspodent Contact martin robert mann
Regulation Number 866.5660
Classification Product Code
MSV  
Date Received 08/22/2011
Decision Date 06/22/2012
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