Cleared Traditional

INNOFLUOR PHENOBARBITAL ASSAY SYSTEM

K972330 · Oxis Intl., Inc. · Toxicology
Jul 1997
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K972330 is an FDA 510(k) clearance for the INNOFLUOR PHENOBARBITAL 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 July 14, 1997, 21 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 K972330 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1997
Decision Date July 14, 1997
Days to Decision 21 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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