Cleared Traditional

INNOFLUOR(TM) QUINDINE CALIBATOR SET

K892212 · Innotron of Oregon, Inc. · Toxicology
Jun 1989
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K892212 is an FDA 510(k) clearance for the INNOFLUOR(TM) QUINDINE CALIBATOR SET, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), 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 862.3200.

Submission Details

510(k) Number K892212 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 DLJ — Calibrators, Drug Specific
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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