Cleared Traditional

INNOFLUOR TOPIRAMATE CONTROL SET

K970517 · Oxis Intl., Inc. · Toxicology
May 1997
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K970517 is an FDA 510(k) clearance for the INNOFLUOR TOPIRAMATE CONTROL SET, a Drug Specific Control Materials (Class I — General Controls, product code LAS), 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 862.3280.

Submission Details

510(k) Number K970517 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

Device Classification

Product Code LAS — Drug Specific Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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