ARCHITECT CYCLOSPORINE


Device Classification Name

cyclosporine

510(k) Number K080751
Device Name ARCHITECT CYCLOSPORINE
Applicant
FUJIREBIO DIAGNOSTICS, INC.
201 great valley pkwy.
malvern, 
PA 
19355 -1307

Applicant Contact stacey moll
Correspondent
FUJIREBIO DIAGNOSTICS, INC.
201 great valley pkwy.
malvern, 
PA 
19355 -1307

Correspodent Contact stacey moll
Regulation Number 862.1235
Classification Product Code
MKW  
Subsequent Product Code
DLJ  
Date Received 03/18/2008
Decision Date 09/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls