Cleared Traditional

INNOFLUOR THEOPHYLLINE ASSAY SYSTEM

K955567 · Oxis Intl., Inc. · Toxicology
Jan 1996
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K955567 is an FDA 510(k) clearance for the INNOFLUOR THEOPHYLLINE ASSAY SYSTEM, a Fluorescence Polarization Immunoassay, Theophylline (Class II — Special Controls, product code LGS), submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on January 24, 1996, 49 days after receiving the submission on December 6, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K955567 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1995
Decision Date January 24, 1996
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LGS — Fluorescence Polarization Immunoassay, Theophylline
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3880

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