Cleared Traditional

ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS

K103627 · Abbott Laboratories · Toxicology

Oct 2011

Decision

305d

Days

Class 2

Risk

About This 510(k) Submission

K103627 is an FDA 510(k) clearance for the ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 14, 2011, 305 days after receiving the submission on December 13, 2010. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number	K103627 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2010
Decision Date	October 14, 2011
Days to Decision	305 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF