510(k) K103627

Device

ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS

Applicant

ABBOTT LABORATORIES

510(k) number

K103627

Product code

KLT  

Decision

Substantially Equivalent (SESE)

Decision date

2011-10-14

Date received

2010-12-13

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