Cleared Traditional

INNOFLUOR GENTAMICIN ASSAY SYSTEM

K955569 · Oxis Intl., Inc. · Toxicology
Feb 1996
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K955569 is an FDA 510(k) clearance for the INNOFLUOR GENTAMICIN ASSAY SYSTEM, a Fluorescent Immunoassay Gentamicin (Class II — Special Controls, product code LCQ), submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on February 9, 1996, 65 days after receiving the submission on December 6, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K955569 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1995
Decision Date February 09, 1996
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCQ — Fluorescent Immunoassay Gentamicin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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