Cleared Traditional

ANTIBODY TO MUMPS VIRUS IFA TEST

K822826 · Electro-Nucleonics Laboratories, Inc. · Microbiology
Dec 1982
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K822826 is an FDA 510(k) clearance for the ANTIBODY TO MUMPS VIRUS IFA TEST, a Antiserum, Fluorescent, Mumps Virus (Class I — General Controls, product code GRA), submitted by Electro-Nucleonics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982, 73 days after receiving the submission on September 21, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3380.

Submission Details

510(k) Number K822826 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1982
Decision Date December 03, 1982
Days to Decision 73 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