Cleared Traditional

LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (K974302) - FDA 510(k) Clearance

Class I Microbiology device.

K974302 · Light Diagnostics · Microbiology device
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Optimized for regulatory review, auditing and printing
Apr 1998
Decision
142d
Days
Class 1
Risk

K974302 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B. Classified as Antisera, Cf, Influenza Virus A, B, C (product code GNW), Class I - General Controls.

Submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on April 8, 1998 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3330 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Light Diagnostics devices

Submission Details

510(k) Number K974302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date April 08, 1998
Days to Decision 142 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 102d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNW Antisera, Cf, Influenza Virus A, B, C
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3330
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.