MAS IMMUNOSUPPRESSANT CONTROLS


Device Classification Name

drug specific control materials

510(k) Number K051074
Device Name MAS IMMUNOSUPPRESSANT CONTROLS
Applicant
MICROGENICS CORP.
46360 fremont blvd.
fremont, 
CA 
94538

Applicant Contact lisa charter
Correspondent
MICROGENICS CORP.
46360 fremont blvd.
fremont, 
CA 
94538

Correspodent Contact lisa charter
Regulation Number 862.3280
Classification Product Code
LAS  
Date Received 04/27/2005
Decision Date 06/06/2005
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