Cleared Traditional

RSV ANTIGEN CONTROL SLIDES

K964870 · Viral Antigens, Inc. · Microbiology

Mar 1997

Decision

103d

Days

Class 1

Risk

About This 510(k) Submission

K964870 is an FDA 510(k) clearance for the RSV ANTIGEN CONTROL SLIDES, a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I — General Controls, product code GQG), submitted by Viral Antigens, Inc. (Memphis, US). The FDA issued a Cleared decision on March 18, 1997, 103 days after receiving the submission on December 5, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number	K964870 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 1996
Decision Date	March 18, 1997
Days to Decision	103 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	GQG — Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.3480