Cleared Traditional

D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT

K081746 · Diagnostic Hybrids, Inc. · Microbiology
Dec 2008
Decision
187d
Days
Class 1
Risk

About This 510(k) Submission

K081746 is an FDA 510(k) clearance for the D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING 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 December 23, 2008, 187 days after receiving the submission on June 19, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number K081746 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2008
Decision Date December 23, 2008
Days to Decision 187 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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