THERMO SCIENTIFIC MAS R DOA TOTAL


Device Classification Name

drug mixture control materials

510(k) Number K103656
Device Name THERMO SCIENTIFIC MAS R DOA TOTAL
Applicant
Microgenics Corporation
46360 fremont blvd.
fremont, 
CA 
94538

Applicant Contact lisa charter
Correspondent
Microgenics Corporation
46360 fremont blvd.
fremont, 
CA 
94538

Correspodent Contact lisa charter
Regulation Number 862.3280
Classification Product Code
DIF  
Date Received 12/15/2010
Decision Date 03/24/2011
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