Cleared Traditional

D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT

K093415 · Diagnostic Hybrids, Inc. · Microbiology
Dec 2009
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K093415 is an FDA 510(k) clearance for the D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT, a Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 (Class I — General Controls, product code GQS), submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on December 23, 2009, 51 days after receiving the submission on November 2, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3400.

Submission Details

510(k) Number K093415 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2009
Decision Date December 23, 2009
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GQS — Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3400

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