Cleared Special

REMEL XPECT FLU A&B

K131804 · Remel, Inc. · Microbiology
Jul 2013
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K131804 is an FDA 510(k) clearance for the REMEL XPECT FLU A&B, a Antigens, Cf (including Cf Control), Influenza Virus A, B, C (Class I — General Controls, product code GNX), submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on July 12, 2013, 23 days after receiving the submission on June 19, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number K131804 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2013
Decision Date July 12, 2013
Days to Decision 23 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GNX — Antigens, Cf (including Cf Control), Influenza Virus A, B, C
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3330

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