Cleared Traditional

MUMPS VIRUS

K894624 · Bion Ent., Ltd. · Microbiology
Oct 1989
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K894624 is an FDA 510(k) clearance for the MUMPS VIRUS, a Antiserum, Fluorescent, Mumps Virus (Class I — General Controls, product code GRA), submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on October 16, 1989, 88 days after receiving the submission on July 20, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3380.

Submission Details

510(k) Number K894624 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1989
Decision Date October 16, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GRA — Antiserum, Fluorescent, Mumps Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3380