Cleared Traditional

MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA

K900702 · Innotron of Oregon, Inc. · Toxicology
Apr 1990
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K900702 is an FDA 510(k) clearance for the MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA, a Fluorescence Polarization Immunoassay, Carbamazepine (Class II — Special Controls, product code LGI), submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on April 12, 1990, 59 days after receiving the submission on February 12, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K900702 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1990
Decision Date April 12, 1990
Days to Decision 59 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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