Cleared Traditional

RESPIRATORY SYNCYTIAL VIRUS ID REAGENT

K853695 · Viromed Laboratories, Inc. · Microbiology

Dec 1985

Decision

91d

Days

Class 1

Risk

About This 510(k) Submission

K853695 is an FDA 510(k) clearance for the RESPIRATORY SYNCYTIAL VIRUS ID REAGENT, a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I — General Controls, product code GQG), submitted by Viromed Laboratories, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 4, 1985, 91 days after receiving the submission on September 4, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number	K853695 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 1985
Decision Date	December 04, 1985
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—

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