Cleared Traditional

K940374 - QMS CARBAMAZEPINE ASSAY
(FDA 510(k) Clearance)

K940374 · Seradyn, Inc. · Toxicology

Jun 1994

Decision

127d

Days

Class 2

Risk

K940374 is an FDA 510(k) clearance for the QMS CARBAMAZEPINE ASSAY, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 2, 1994, 127 days after receiving the submission on January 26, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number	K940374 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 1994
Decision Date	June 02, 1994
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF