Cleared Traditional

INNOFLOUR TOPIRAMATE REAGENT SET

K970510 · Oxis Intl., Inc. · Toxicology

May 1997

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K970510 is an FDA 510(k) clearance for the INNOFLOUR TOPIRAMATE REAGENT SET, a System, Test, Topiramatee (Class II — Special Controls, product code MSL), submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on May 12, 1997, 90 days after receiving the submission on February 11, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K970510 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 1997
Decision Date	May 12, 1997
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF