Cleared Traditional

INNOFLUOR (TM) AMIKACIN REAGENT SET

K903100 · Innotron of Oregon, Inc. · Toxicology
Aug 1990
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K903100 is an FDA 510(k) clearance for the INNOFLUOR (TM) AMIKACIN REAGENT SET, a Radioimmunoassay, Amikacin (Class II — Special Controls, product code KLQ), submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on August 9, 1990, 27 days after receiving the submission on July 13, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3035.

Submission Details

510(k) Number K903100 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1990
Decision Date August 09, 1990
Days to Decision 27 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code KLQ — Radioimmunoassay, Amikacin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3035

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