Cleared Traditional

RUBELLA ANTIGEN AND CONTROL ANTIGEN

K894262 · Microbix Biosystems, Inc. · Microbiology
Oct 1989
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K894262 is an FDA 510(k) clearance for the RUBELLA ANTIGEN AND CONTROL ANTIGEN, a Antigen, Cf (including Cf Control), Rubella (Class II — Special Controls, product code GON), submitted by Microbix Biosystems, Inc. (Flemington, US). The FDA issued a Cleared decision on October 16, 1989, 117 days after receiving the submission on June 21, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K894262 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 1989
Decision Date October 16, 1989
Days to Decision 117 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GON — Antigen, Cf (including Cf Control), Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510