Cleared Traditional

DFA RESPIRATORY VIRUS SCREENING & ID KIT

K022713 · Diagnostic Hybrids, Inc. · Microbiology
Dec 2002
Decision
126d
Days
Class 1
Risk

About This 510(k) Submission

K022713 is an FDA 510(k) clearance for the DFA RESPIRATORY VIRUS SCREENING & ID 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 18, 2002, 126 days after receiving the submission on August 14, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number K022713 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2002
Decision Date December 18, 2002
Days to Decision 126 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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