CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS


Device Classification Name

mycophenolic acid test system

510(k) Number K081083
Device Name CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
Applicant
Thermo Fisher Scientific
46360 fremont blvd.
fremont, 
CA 
94538

Applicant Contact jack rogers
Correspondent
Thermo Fisher Scientific
46360 fremont blvd.
fremont, 
CA 
94538

Correspodent Contact jack rogers
Regulation Number 862.3840
Classification Product Code
OAV  
Subsequent Product Codes
DLJ   LAS  
Date Received 04/16/2008
Decision Date 12/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No