CEDIA CYCLOSPORINE PLUS ASSAY


Device Classification Name

cyclosporine

510(k) Number K023208
Device Name CEDIA CYCLOSPORINE PLUS ASSAY
Original Applicant
MICROGENICS CORP.
46360 fremont blvd.
fremont, 
CA 
94538

Original Contact mark hamilton smith
Regulation Number 862.1235
Classification Product Code
MKW  
Subsequent Product Code
JIS  
Date Received 09/25/2002
Decision Date 10/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls