Cleared Traditional

K940682 - AXSYM(TM) QUINIDINE
(FDA 510(k) Clearance)

K940682 · Abbott Laboratories · Chemistry

Jun 1994

Decision

131d

Days

Class 2

Risk

K940682 is an FDA 510(k) clearance for the AXSYM(TM) QUINIDINE, a Fluorescence Polarization Immunoassay, Carbamazepine (Class II — Special Controls, product code LGI), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 21, 1994, 131 days after receiving the submission on February 10, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number	K940682 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 1994
Decision Date	June 21, 1994
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF