Cleared Traditional

FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT

K853067 · Idt, A Division of Whittaker M.A. Bioproducts · Microbiology
Oct 1985
Decision
92d
Days
Class 1
Risk

About This 510(k) Submission

K853067 is an FDA 510(k) clearance for the FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT, a Antiserum, Fluorescent, Rubeola (Class I — General Controls, product code GRE), submitted by Idt, A Division of Whittaker M.A. Bioproducts (San Jose, US). The FDA issued a Cleared decision on October 22, 1985, 92 days after receiving the submission on July 22, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3520.

Submission Details

510(k) Number K853067 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1985
Decision Date October 22, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GRE — Antiserum, Fluorescent, Rubeola
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3520