Cleared Traditional

RESUBMITTED MODIFIED RUBALEX

K901637 · Orion Corp. · Microbiology
Apr 1990
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K901637 is an FDA 510(k) clearance for the RESUBMITTED MODIFIED 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 April 26, 1990, 17 days after receiving the submission on April 9, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K901637 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1990
Decision Date April 26, 1990
Days to Decision 17 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