Cleared Traditional

D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT

K092882 · Diagnostic Hybrids, Inc. · Microbiology
Oct 2009
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K092882 is an FDA 510(k) clearance for the D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT, a Antisera, Cf, Influenza Virus A, B, C (Class I — General Controls, product code GNW), submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on October 21, 2009, 33 days after receiving the submission on September 18, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number K092882 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2009
Decision Date October 21, 2009
Days to Decision 33 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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