Cleared Traditional

INNOFLUOR(TM) QUINIDINE REAGENT SET

K892208 · Innotron of Oregon, Inc. · Toxicology
Jun 1989
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K892208 is an FDA 510(k) clearance for the INNOFLUOR(TM) QUINIDINE REAGENT SET, a Enzyme Immunoassay, Quinidine (Class II — Special Controls, product code LBZ), submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on June 9, 1989, 67 days after receiving the submission on April 3, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K892208 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1989
Decision Date June 09, 1989
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LBZ — Enzyme Immunoassay, Quinidine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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