510(k) K063131

Device

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS

Applicant

THERMO ELECTRON OY

510(k) number

K063131

Product code

KLT  

Decision

Substantially Equivalent (SESE)

Decision date

2007-10-05

Date received

2006-10-13

Regulation

862.3645

Classification name

Enzyme Immunoassay, Carbamazepine

Medical specialty

Toxicology

Review panel

Toxicology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No