Cleared Traditional

INNOFLUOR GENTAMICIN ASSAY SYSTEM

K972331 · Oxis Intl., Inc. · Toxicology
Aug 1997
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K972331 is an FDA 510(k) clearance for the INNOFLUOR GENTAMICIN ASSAY SYSTEM, a Fluorescence Polarization Immunoassay, Phenobarbital (Class II — Special Controls, product code LGQ), submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on August 1, 1997, 39 days after receiving the submission on June 23, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K972331 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1997
Decision Date August 01, 1997
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LGQ — Fluorescence Polarization Immunoassay, Phenobarbital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3660

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