Cleared Special

OSOM INFLUENZA A&B TEST MODEL 190

K123182 · SEKISUI Diagnostics, LLC · Microbiology
Nov 2012
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K123182 is an FDA 510(k) clearance for the OSOM INFLUENZA A&B TEST MODEL 190, a Antigens, Cf (including Cf Control), Influenza Virus A, B, C (Class I — General Controls, product code GNX), submitted by SEKISUI Diagnostics, LLC (San Diegi, US). The FDA issued a Cleared decision on November 5, 2012, 26 days after receiving the submission on October 10, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number K123182 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2012
Decision Date November 05, 2012
Days to Decision 26 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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