CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS


Device Classification Name

drug specific control materials

510(k) Number K080459
Device Name CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS
Applicant
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
1733 canton lane
suite 103
marietta, 
GA 
30062 -2679

Applicant Contact cathy cambria
Correspondent
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
1733 canton lane
suite 103
marietta, 
GA 
30062 -2679

Correspodent Contact cathy cambria
Regulation Number 862.3280
Classification Product Code
LAS  
Date Received 02/20/2008
Decision Date 11/17/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No