MAS TOX CONTROL


Device Classification Name

drug mixture control materials

510(k) Number K080085
Device Name MAS TOX CONTROL
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 862.3280
Classification Product Code
DIF  
Date Received 01/11/2008
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No