Cleared Traditional

PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS

K862743 · Kallestad Laboratories, Inc. · Microbiology

Sep 1986

Decision

70d

Days

Class 1

Risk

About This 510(k) Submission

K862743 is an FDA 510(k) clearance for the PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS, a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I — General Controls, product code GQG), submitted by Kallestad Laboratories, Inc. (Austin, US). The FDA issued a Cleared decision on September 29, 1986, 70 days after receiving the submission on July 21, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number	K862743 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 1986
Decision Date	September 29, 1986
Days to Decision	70 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