THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K110616
Device Name THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
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 862.1660
Classification Product Code
JJY  
Date Received 03/03/2011
Decision Date 06/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls