Cleared Traditional

LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B

K974302 · Light Diagnostics · Microbiology
Apr 1998
Decision
142d
Days
Class 1
Risk

About This 510(k) Submission

K974302 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B, a Antisera, Cf, Influenza Virus A, B, C (Class I — General Controls, product code GNW), submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on April 8, 1998, 142 days after receiving the submission on November 17, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number K974302 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GNW — Antisera, Cf, Influenza Virus A, B, C
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3330

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