Cleared Traditional

INNOFLUOR PHENYTOIN ASSAY SYSTEM

K955562 · Oxis Intl., Inc. · Toxicology

Jan 1996

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K955562 is an FDA 510(k) clearance for the INNOFLUOR PHENYTOIN ASSAY SYSTEM, a Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (Class II — Special Controls, product code LGR), 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 862.3350.

Submission Details

510(k) Number	K955562 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	LGR — Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3350