Cleared Traditional

RUBALEX

K852788 · Orion Corp. · Microbiology
Mar 1986
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K852788 is an FDA 510(k) clearance for the RUBALEX, a Latex Agglutination Assay, Rubella (Class II — Special Controls, product code LQN), submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on March 12, 1986, 254 days after receiving the submission on July 1, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K852788 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1985
Decision Date March 12, 1986
Days to Decision 254 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LQN — Latex Agglutination Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510