MODIFICATION TO MAMMAPRINT


Device Classification Name

classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer

510(k) Number K080252
Device Name MODIFICATION TO MAMMAPRINT
Applicant
AGENDIA BV
louwesweg 6
amsterdam, 

NL

1066 ec

Applicant Contact guido brink
Correspondent
AGENDIA BV
louwesweg 6
amsterdam, 

NL

1066 ec

Correspodent Contact guido brink
Regulation Number 866.6040
Classification Product Code
NYI  
Date Received 01/31/2008
Decision Date 07/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Pathology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls