Cleared Traditional

K944063 - FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
(FDA 510(k) Clearance)

K944063 · Sigma Diagnostics, Inc. · Chemistry
Nov 1994
Decision
83d
Days
Class 2
Risk

K944063 is an FDA 510(k) clearance for the FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE, a Fluorescence Polarization Immunoassay, Carbamazepine (Class II — Special Controls, product code LGI), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 10, 1994, 83 days after receiving the submission on August 19, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K944063 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1994
Decision Date November 10, 1994
Days to Decision 83 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LGI — Fluorescence Polarization Immunoassay, Carbamazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3645