Cleared Traditional

K970517 - INNOFLUOR TOPIRAMATE CONTROL SET

K970517 is an FDA 510(k) clearance for INNOFLUOR TOPIRAMATE CONTROL SET, manufactured by Oxis Intl., Inc.. The device is a Class 1 Toxicology device with product code LAS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

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

Submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on May 12, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Oxis Intl., Inc. devices

FDA 510(k) Submission Details - K970517

510(k) Number K970517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 87d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LAS Device Classification - Class 1, General Controls

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LAS Drug Specific Control Materials

All 69
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K970517.
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K943048 · Microgenics Corp. · Aug 1994