Cleared Traditional

RSV ANTIGEN TEST

K942173 · Neogenex · Microbiology
Jun 1994
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K942173 is an FDA 510(k) clearance for the RSV ANTIGEN TEST, a Respiratory Syncytial Virus, Antigen, Antibody, Ifa (Class I — General Controls, product code LKT), submitted by Neogenex (Everett, US). The FDA issued a Cleared decision on June 30, 1994, 56 days after receiving the submission on May 5, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number K942173 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1994
Decision Date June 30, 1994
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LKT — Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3480

Similar Devices — LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa

All 22
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
K081928 · Diagnostic Hybrids, Inc. · Dec 2008
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
K983336 · Diagnostic Products Corp. · Mar 1999
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
K943317 · Diagnostic Products Corp. · Dec 1994
RSV-MAB TEST
K912842 · Gull Laboratories, Inc. · Dec 1991
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
K912838 · Baxter Diagnostics, Inc. · Sep 1991
BIOMERIEUX RSV DIRECT IF KIT
K912371 · Vitek Systems, Inc. · Sep 1991